Clinical Trial Results:
An open label, randomized, three period, single-dose, crossover study to determine the bioavailability of 300 mg aliskiren mini-tablets relative to the 300 mg aliskiren market tablet under fasted condition and to evaluate the effect of food on the pharmacokinetics of 300 mg aliskiren mini-tablets in healthy subjects
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Summary
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EudraCT number |
2012-000855-15 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
22 Feb 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Oct 2018
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First version publication date |
25 Oct 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CSPP100A2109
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Novartis Pharma AG
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Sponsor organisation address |
CH 4002, Basel, Switzerland,
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Public contact |
Clinical Disclosure Office, Clinical Disclosure Office, +41 613241111,
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Scientific contact |
Clinical Disclosure Office, Clinical Disclosure Office, +41 613241111,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000362-PIP08-04 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
22 Feb 2010
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Feb 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of the trial was to determine the bioavailability of a single oral dose of 300 milligrams (mg) aliskiren mini-tablets relative to the 300 mg aliskiren market tablet under fasted condition in healthy subjects and to evaluate the effect of food on the pharmacokinetics of a single oral dose of 300 mg aliskiren mini-tablets in healthy subjects.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 Dec 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
India: 69
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Worldwide total number of subjects |
69
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
69
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted at one center in India. | ||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 69 subjects were enrolled in the study. | ||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||
Blinding implementation details |
The study was open-label study, hence no blinding was performed.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Mini (fasted) then FMI (fasted) then Mini tablet (fed) | ||||||||||||||||||||||||||||
Arm description |
Subjects were orally administered with single dose of aliskiren equivalent to 300 mg mini-tablets followed by single dose of aliskiren 300 mg final market image (FMI) tablets under fasted conditions and finally with single dose of aliskiren equivalent to 300 mg mini-tablets under fed condition. A washout interval of least 14 days (maximum 21 days) was maintained between two treatments. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Aliskiren
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Investigational medicinal product code |
SPP100
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects after having an overnight fast of at least 10 hours (h) were orally administered with single dose of aliskiren equivalent to 300 mg mini-tablets administered with a teaspoon of low fat vanilla ice cream followed by single dose of aliskiren 300 mg FMI tablets, administered with 240 milliliters (mL) of water under fasted condition. Subjects continued to fast till 4 h post dose, during which they were served a standard lunch. Finally subjects received a single dose of aliskiren equivalent to 300 mg mini-tablets, administered with a teaspoon of low fat vanilla ice cream followed by 240 mL of water under fed condition. Dosing of which, was done 30 minutes after start of a USFDA recommended standard high-fat breakfast. Throughout water was not allowed 1 h before and 1 h after dose except that taken with the study medication. Water was then made available as and when needed. A washout interval of least 14 days (maximum 21 days) was maintained between two treatments.
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Arm title
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FMI (fasted) then Mini (fed) then Mini tablet (fasted) | ||||||||||||||||||||||||||||
Arm description |
Subjects were orally administered with single dose of aliskiren 300 mg FMI tablets under fasted conditions followed by single dose of aliskiren equivalent to 300 mg mini-tablets under fed condition and finally with single dose of aliskiren equivalent to 300 mg mini-tablets tablets under fasted conditions. A washout interval of least 14 days (maximum 21 days) was maintained between two treatments. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Aliskiren
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Investigational medicinal product code |
SPP100
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects after having an overnight fast of at least 10 h were orally administered with single dose of aliskiren 300 mg FMI tablets, administered with 240 mL of water under fasted condition followed by a single dose of aliskiren equivalent to 300 mg mini-tablets, administered with a teaspoon of low fat vanilla ice cream followed by 240 mL of water under fed condition. Dosing was done 30 minutes after start of a USFDA recommended standard high-fat breakfast. Finally subjects received a single dose of aliskiren equivalent to 300 mg mini-tablets administered with a teaspoon of low fat vanilla ice cream followed by 240 mL of water under fasted condition. Subjects continued to fast till 4 h post dose and were served a standard lunch. Throughout water was not allowed 1 h before and 1 h after dose except that taken with the study medication. Water was then made available as and when needed. A washout interval of least 14 days (maximum 21 days) was maintained between two treatments.
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Arm title
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Mini (fed) then Mini (fasted) then FMI tablet (fasted) | ||||||||||||||||||||||||||||
Arm description |
Subjects were orally administered with single dose of aliskiren equivalent to 300 mg mini-tablets under fed condition followed by single dose of aliskiren equivalent to 300 mg mini-tablets tablets under fasted conditions and finally with single dose of aliskiren 300 mg FMI tablets under fasted conditions. A washout interval of least 14 days (maximum 21 days) was maintained between two treatments. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Aliskiren
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Investigational medicinal product code |
SPP100
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects after having an overnight fast were orally administered with single dose of aliskiren equivalent to 300 mg mini-tablets, administered with a teaspoon of low fat vanilla ice cream followed by 240 mL of water under fed condition. Dosing was done 30 minutes after start of a USFDA recommended standard high-fat breakfast followed by single dose of aliskiren equivalent to 300 mg mini-tablets administered with a teaspoon of low fat vanilla ice cream followed by 240 mL of water under fasted condition. Finally subjects received a single dose of aliskiren 300 mg FMI tablets, administered with 240 mL of water under fasted condition. Subjects continued to fast till 4 h post dose, during which they were served a standard lunch. Throughout water was not allowed 1 h before and 1 h after dose except that taken with the study medication. Water was then made available as and when needed. A washout interval of least 14 days (maximum 21 days) was maintained between two treatments.
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Baseline characteristics reporting groups
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Reporting group title |
Mini (fasted) then FMI (fasted) then Mini tablet (fed)
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Reporting group description |
Subjects were orally administered with single dose of aliskiren equivalent to 300 mg mini-tablets followed by single dose of aliskiren 300 mg final market image (FMI) tablets under fasted conditions and finally with single dose of aliskiren equivalent to 300 mg mini-tablets under fed condition. A washout interval of least 14 days (maximum 21 days) was maintained between two treatments. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
FMI (fasted) then Mini (fed) then Mini tablet (fasted)
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Reporting group description |
Subjects were orally administered with single dose of aliskiren 300 mg FMI tablets under fasted conditions followed by single dose of aliskiren equivalent to 300 mg mini-tablets under fed condition and finally with single dose of aliskiren equivalent to 300 mg mini-tablets tablets under fasted conditions. A washout interval of least 14 days (maximum 21 days) was maintained between two treatments. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Mini (fed) then Mini (fasted) then FMI tablet (fasted)
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Reporting group description |
Subjects were orally administered with single dose of aliskiren equivalent to 300 mg mini-tablets under fed condition followed by single dose of aliskiren equivalent to 300 mg mini-tablets tablets under fasted conditions and finally with single dose of aliskiren 300 mg FMI tablets under fasted conditions. A washout interval of least 14 days (maximum 21 days) was maintained between two treatments. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Mini (fasted) then FMI (fasted) then Mini tablet (fed)
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Reporting group description |
Subjects were orally administered with single dose of aliskiren equivalent to 300 mg mini-tablets followed by single dose of aliskiren 300 mg final market image (FMI) tablets under fasted conditions and finally with single dose of aliskiren equivalent to 300 mg mini-tablets under fed condition. A washout interval of least 14 days (maximum 21 days) was maintained between two treatments. | ||
Reporting group title |
FMI (fasted) then Mini (fed) then Mini tablet (fasted)
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Reporting group description |
Subjects were orally administered with single dose of aliskiren 300 mg FMI tablets under fasted conditions followed by single dose of aliskiren equivalent to 300 mg mini-tablets under fed condition and finally with single dose of aliskiren equivalent to 300 mg mini-tablets tablets under fasted conditions. A washout interval of least 14 days (maximum 21 days) was maintained between two treatments. | ||
Reporting group title |
Mini (fed) then Mini (fasted) then FMI tablet (fasted)
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Reporting group description |
Subjects were orally administered with single dose of aliskiren equivalent to 300 mg mini-tablets under fed condition followed by single dose of aliskiren equivalent to 300 mg mini-tablets tablets under fasted conditions and finally with single dose of aliskiren 300 mg FMI tablets under fasted conditions. A washout interval of least 14 days (maximum 21 days) was maintained between two treatments. | ||
Subject analysis set title |
Mini tablet (fasted)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects after having an overnight fast of at least 10 h were orally administered with single dose of aliskiren equivalent to 300 mg mini-tablets administered with a teaspoon of low fat vanilla ice cream followed by 240 mL of water under fasted condition. Subjects continued to fast till 4 h post dose, during which they were served a standard lunch. Water was not allowed 1 h before and 1 h after dose except that taken with the study medication. Water was then made available as and when needed.
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Subject analysis set title |
FMI tablet (fasted)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects after having an overnight fast of at least 10 h were orally administered with single dose of aliskiren 300 mg FMI tablets, administered with 240 mL of water under fasted condition. Subjects continued to fast till 4 h post dose, during which they were served a standard lunch. Water was not allowed 1 h before and 1 h after dose except that taken with the study medication. Water was then made available as and when needed.
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Subject analysis set title |
Mini tablet (fed)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects after having an overnight fast were orally administered with single dose of aliskiren equivalent to 300 mg mini-tablets, administered with a teaspoon of low fat vanilla ice cream followed by 240 mL of water under fed condition. Dosing was done 30 minutes after start of a USFDA recommended standard high-fat breakfast. Water was not allowed 1 h before and 1 h after dose except that taken with the study medication. Water was then made available as and when needed.
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End point title |
Area under the curve from time zero to the last measurable concentration sampling time (AUClast) of aliskiren | ||||||||||||||||
End point description |
AUClast was defined as the area under the plasma concentration-time curve up to the last measurable concentration time point and was calculated as the sum of linear trapezoids using non-compartmental analysis were determined using WinNonlin Pro (Version 5.0.1). Plasma concentrations of aliskiren was analyzed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay with a lower limit of quantification (LLOQ) of 0.5 nanogram (ng)/mL. The analysis was performed on pharmacokinetic (PK) analysis set (PAS) defined as all subjects who completed at least one treatment period with evaluable aliskiren PK data.
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.25 h, 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h at Day 1; Day 2, Day 3, Day 4, Day 5, Day 7 and Day 8 post dose
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Statistical analysis title |
Bioavailability: AUClast of aliskiren | ||||||||||||||||
Statistical analysis description |
Comparison of AUClast for Mini tablet fasted with FMI tablet fasted was evaluated to determine the bioavailability of a single oral dose of 300 mg mini-tablets relative to the 300 mg FMI tablet under fasted condition. The number of subjects analyzed for this end point were 60 and 61 respectively, but since this is a cross-over study, the subjects analyzed feature as 121 below, which is the total of the two arms that are being compared [Mini tablet fasted (N=60) and FMI tablet fasted (N=61)].
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Comparison groups |
Mini tablet (fasted) v FMI tablet (fasted)
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Number of subjects included in analysis |
121
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
Method |
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Parameter type |
Geometric mean ratio | ||||||||||||||||
Point estimate |
1.02
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Confidence interval |
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level |
90% | ||||||||||||||||
sides |
2-sided
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lower limit |
0.92 | ||||||||||||||||
upper limit |
1.14 | ||||||||||||||||
Statistical analysis title |
Food effect: AUClast of aliskiren | ||||||||||||||||
Statistical analysis description |
Comparison of AUClast for Mini tablet fed with Mini tablet fasted was evaluated to determine the effect of food on the pharmacokinetics of a single oral dose of 300 mg mini-tablets. The number of subjects analyzed for this end point were 62 and 60 respectively, but since this is a cross-over study, the subjects analyzed feature as 122 below, which is the total of the two arms that are being compared [Mini tablet fed (N=62) and Mini tablet fasted (N=60)].
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Comparison groups |
Mini tablet (fed) v Mini tablet (fasted)
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Number of subjects included in analysis |
122
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
Method |
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Parameter type |
Geometric mean ratio | ||||||||||||||||
Point estimate |
0.16
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Confidence interval |
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level |
90% | ||||||||||||||||
sides |
2-sided
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lower limit |
0.14 | ||||||||||||||||
upper limit |
0.18 | ||||||||||||||||
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End point title |
Area under the concentration-time curve to infinity (AUCinf) of aliskiren | ||||||||||||||||
End point description |
AUCinf was defined as the area under the curve from time zero to infinity. AUCinf was calculated using non-compartmental methods using WinNonlin Pro (Version 5.0.1) by adding area under the curve from time zero to the last measurable concentration sampling time (AUClast) and the value obtained from dividing the last measurable plasma concentration (Clast) by terminal elimination rate constant (ke). Plasma concentrations of aliskiren was analyzed using a validated LC-MS/MS assay with LLOQ of 0.5 ng/mL. The analysis was performed on PAS population.
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.25 h, 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h at Day 1; Day 2, Day 3, Day 4, Day 5, Day 7 and Day 8 post dose
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Statistical analysis title |
Bioavailability: AUCinf of aliskiren | ||||||||||||||||
Statistical analysis description |
Comparison of AUCinf for Mini tablet fasted with FMI tablet fasted was evaluated to determine the bioavailability of a single oral dose of 300 mg mini-tablets relative to the 300 mg FMI tablet under fasted condition. The number of subjects analyzed for this end point were 60 and 61 respectively, but since this is a cross-over study,the subjects analyzed feature as 121 below, which is the total of the two arms that are being compared [Mini tablet fasted (N=60) and FMI tablet fasted (N=61)].
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Comparison groups |
Mini tablet (fasted) v FMI tablet (fasted)
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Number of subjects included in analysis |
121
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
Method |
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Parameter type |
Geometric mean ratio | ||||||||||||||||
Point estimate |
1.01
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Confidence interval |
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level |
90% | ||||||||||||||||
sides |
2-sided
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lower limit |
0.91 | ||||||||||||||||
upper limit |
1.12 | ||||||||||||||||
Statistical analysis title |
Food effect: AUCinf of aliskiren | ||||||||||||||||
Statistical analysis description |
Comparison of AUClast for Mini tablet fed with Mini tablet fasted was evaluated to determine the effect of food on the pharmacokinetics of a single oral dose of 300 mg mini-tablets. The number of subjects analyzed for this end point were 62 and 60 respectively, but since this is a cross-over study, the subjects analyzed feature as 122 below, which is the total of the two arms that are being compared [Mini tablet fed (N=62) and Mini tablet fasted (N=60)].
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Comparison groups |
Mini tablet (fasted) v Mini tablet (fed)
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Number of subjects included in analysis |
122
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
Method |
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Parameter type |
Geometric mean ratio | ||||||||||||||||
Point estimate |
0.17
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Confidence interval |
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level |
90% | ||||||||||||||||
sides |
2-sided
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lower limit |
0.15 | ||||||||||||||||
upper limit |
0.19 | ||||||||||||||||
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End point title |
Maximum plasma concentration (Cmax) of aliskiren | ||||||||||||||||
End point description |
Cmax was defined as the maximum (peak) observed drug concentration in blood after single dose administration. Cmax was directly determined from the raw plasma concentration-time data using WinNonLin Professional version 5.2. Plasma concentrations of aliskiren was analyzed using a validated LC-MS/MS assay with LLOQ of 0.5 ng/mL. The analysis was performed on PAS population.
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.25 h, 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h at Day 1; Day 2, Day 3, Day 4, Day 5, Day 7 and Day 8 post dose
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Statistical analysis title |
Bioavailability: Cmax of aliskiren | ||||||||||||||||
Statistical analysis description |
Comparison of Cmax for Mini tablet fasted with FMI tablet fasted was evaluated to determine the bioavailability of a single oral dose of 300 mg mini-tablets relative to the 300 mg FMI tablet under fasted condition. The number of subjects analyzed for this end point were 60 and 61 respectively, but since this is a cross-over study,the subjects analyzed feature as 121 below, which is the total of the two arms that are being compared [Mini tablet fasted (N=60) and FMI tablet fasted (N=61)].
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Comparison groups |
Mini tablet (fasted) v FMI tablet (fasted)
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Number of subjects included in analysis |
121
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
Method |
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Parameter type |
Geometric mean ratio | ||||||||||||||||
Point estimate |
1.06
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Confidence interval |
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level |
90% | ||||||||||||||||
sides |
2-sided
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lower limit |
0.94 | ||||||||||||||||
upper limit |
1.21 | ||||||||||||||||
Statistical analysis title |
Food effect: Cmax of aliskiren | ||||||||||||||||
Statistical analysis description |
Comparison of Cmax for Mini tablet fed with Mini tablet fasted was evaluated to determine the effect of food on the pharmacokinetics of a single oral dose of 300 mg mini-tablets. The number of subjects analyzed for this end point were 62 and 60 respectively, but since this is a cross-over study, the subjects analyzed feature as 122 below, which is the total of the two arms that are being compared [Mini tablet fed (N=62) and Mini tablet fasted (N=60)].
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Comparison groups |
Mini tablet (fasted) v Mini tablet (fed)
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Number of subjects included in analysis |
122
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
Method |
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Parameter type |
Geometric mean ratio | ||||||||||||||||
Point estimate |
0.05
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Confidence interval |
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level |
90% | ||||||||||||||||
sides |
2-sided
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lower limit |
0.04 | ||||||||||||||||
upper limit |
0.05 | ||||||||||||||||
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End point title |
Time to reach maximum (peak) drug concentration (Tmax ) of aliskiren [1] | ||||||||||||||||
End point description |
Tmax was defined as the time to reach maximum (peak) drug concentration after single dose administration. Tmax was directly determined from the raw plasma concentration-time data using WinNonLin Professional version 5.2. Plasma concentrations of aliskiren was analyzed using a validated LC-MS/MS assay with LLOQ of 0.5 ng/mL. The analysis was performed on PAS population.
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.25 h, 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h at Day 1; Day 2, Day 3, Day 4, Day 5, Day 7 and Day 8 post dose
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive summary statistics was planned for this outcome measure. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
The elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (T1/2) of aliskiren [2] | ||||||||||||||||
End point description |
T1/2 was defined as the elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve. T1/2 was calculated using non-compartmental methods using WinNonlin Pro (Version 5.0.1) calculated as Ln2/ke. Plasma concentrations of aliskiren was analyzed using a validated LC-MS/MS assay with LLOQ of 0.5 ng/mL. The analysis was performed on PAS population.
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.25 h, 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h at Day 1; Day 2, Day 3, Day 4, Day 5, Day 7 and Day 8 post dose
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive summary statistics was planned for this outcome measure. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
The apparent total body clearance of drug from the plasma (CL/F) of aliskiren [3] | ||||||||||||||||
End point description |
CL/F was defined as the apparent clearance of a drug from the blood after oral administration. CL/F was analyzed using non-compartmental methods using WinNonlin Pro (Version 5.0.1). Plasma concentrations of aliskiren was analyzed using a validated LC-MS/MS assay with LLOQ of 0.5 ng/mL. The analysis was performed on PAS population.
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End point type |
Primary
|
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End point timeframe |
Pre-dose, 0.25 h, 0.5 h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h at Day 1; Day 2, Day 3, Day 4, Day 5, Day 7 and Day 8 post dose
|
||||||||||||||||
| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive summary statistics was planned for this outcome measure. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Number of subjects with Adverse Events (AEs), Serious Adverse Events (SAEs), AE leading to discontinuation and who died | ||||||||||||||||||||||||||||
End point description |
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. The analysis was performed on safety set population defined as all subjects who received at least one dose of the study drug.
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End point type |
Secondary
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End point timeframe |
From Day 1 to 30 days after the last subject treatment (approximately 30 days)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.1
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Reporting groups
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Reporting group title |
Mini-tablets fed
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Reporting group description |
Subjects after having an overnight fast were orally administered with single dose of aliskiren equivalent to 300 mg mini-tablets, administered with a teaspoon of low fat vanilla ice cream followed by 240 mL of water under fed condition. Dosing was done 30 minutes after start of a USFDA recommended standard high-fat breakfast. Water was not allowed 1 h before and 1 h after dose except that taken with the study medication. Water was then made available as and when needed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Market-tablet fasted
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Reporting group description |
Subjects after having an overnight fast of at least 10 h were orally administered with single dose of aliskiren 300 mg FMI tablets, administered with 240 mL of water under fasted condition. Subjects continued to fast till 4 h post dose, during which they were served a standard lunch. Water was not allowed 1 h before and 1 h after dose except that taken with the study medication. Water was then made available as and when needed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
All Subjects
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Reporting group description |
Subjects after having an overnight fast of at least 10 h were orally administered with aliskiren, administered with 240 mL of water under fasted condition. Water was not allowed 1 h before and 1 h after dose except that taken with the study medication. Water was then made available as and when needed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Mini-tablets fasted
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Reporting group description |
Subjects after having an overnight fast of at least 10 h were orally administered with single dose of aliskiren equivalent to 300 mg mini-tablets administered with a teaspoon of low fat vanilla ice cream followed by 240 mL of water under fasted condition. Subjects continued to fast till 4 h post dose, during which they were served a standard lunch. Water was not allowed 1 h before and 1 h after dose except that taken with the study medication. Water was then made available as and when needed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
