Clinical Trial Results:
An Ascending Bioavailability of a New Oral Suspension of E3810
Summary
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EudraCT number |
2016-001896-63 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
23 Jul 2005
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Jul 2016
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First version publication date |
28 Jul 2016
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Other versions |
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 |
E3810-A001-015
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Eisai Medical Research Inc.
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Sponsor organisation address |
100 Tice Boulevard, Woodcliff Lake, United States, 07677
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Public contact |
Eisai Medical Information, Eisai Medical Research Inc., 1 8882472378, esi_medinfo@eisai.com
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Scientific contact |
Eisai Medical Information, Eisai Medical Research Inc., 1 8882472378, esi_medinfo@eisai.com
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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-000055-PIP01-07 | ||
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 |
23 Jul 2005
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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 |
23 Jul 2005
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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 primary objective of this study was to evaluate the bioavailability of a new rabeprazole formulation, consisting of enteric-coated microgranules, relative to the currently marketed 10-mg tablet formulation.
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Protection of trial subjects |
This study was conducted in accordance with standard operating procedures (SOPs) of the sponsor (or designee), which are designed to ensure adherence to Good Clinical Practice (GCP) guidelines as required by the following:
- Principles of the World Medical Association Declaration of Helsinki (World Medical Association, 2008)
- International Council on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal
Products, Committee for Proprietary Medicinal Products, International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- Title 21 of the United States (US) Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and Institutional Review Board (IRB) regulations and applicable sections of US 21 CFR Part 312
- European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country. All suspected unexpected serious adverse reactions were reported, as required, to the Competent Authorities of all involved EU member states.
- Article 14, Paragraph 3, and Article 80-2 of the Pharmaceutical Affairs Law (Law No. 145, 1960) for studies conducted in Japan, in addition to Japan’s GCP Subject Information and Informed Consent.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Jun 2005
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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 |
United States: 16
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Worldwide total number of subjects |
16
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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) |
16
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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 |
- | ||||||||||
Pre-assignment
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Screening details |
This was an open-label, 2-period, 2-sequence crossover study. Sixteen participants, 15 of whom received both formulations, were enrolled at one investigative center. Participants were randomized to one of two sequences: Reference (10-mg tablet) follow by Test (new enteric-coated microgranule formulation), or Test followed by Reference. | ||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Reference/Test then Test/Reference | ||||||||||
Arm description |
Period 1: Participants were randomized to either rabeprazole tablet (Reference) or enteric-coated microgranule rabeprazole oral suspension (Test). After at least a 1 week washout, participants returned to the clinic and entered into Period 2. In Period 2, participants who received Reference study drug in Period 1 crossed over to Test study drug. Participants who received Test study drug in Period 1 crossed over to Reference study drug. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Rabeprazole sodium tablet
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Investigational medicinal product code |
E3810
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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 |
Period 1: Following a 10-hour overnight fast participants were randomized to receive either 10-mg rabeprazole sodium tablet or 10-mg oral suspension of enteric-coated microgranule rabeprazole sodium oral suspension. Period 2: Following at least a 1 week washout period, and 10-hour overnight fast, participants received the other formulation of study drug, either 10-mg rabeprazole sodium tablet (if they received the oral suspension formulation in Period 1) or enteric-coated microgranule 10-mg rabeprazole sodium oral suspension (if they received the tablet formulation in Period 1).
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Baseline characteristics reporting groups
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Reporting group title |
Reference/Test then Test/Reference
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Reporting group description |
Period 1: Participants were randomized to either rabeprazole tablet (Reference) or enteric-coated microgranule rabeprazole oral suspension (Test). After at least a 1 week washout, participants returned to the clinic and entered into Period 2. In Period 2, participants who received Reference study drug in Period 1 crossed over to Test study drug. Participants who received Test study drug in Period 1 crossed over to Reference study drug. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Reference/Test then Test/Reference
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Reporting group description |
Period 1: Participants were randomized to either rabeprazole tablet (Reference) or enteric-coated microgranule rabeprazole oral suspension (Test). After at least a 1 week washout, participants returned to the clinic and entered into Period 2. In Period 2, participants who received Reference study drug in Period 1 crossed over to Test study drug. Participants who received Test study drug in Period 1 crossed over to Reference study drug. | ||
Subject analysis set title |
Rabeprazole sodium (Reference)
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Evaluable population included all participants who satisfied all inclusion and none of the exclusion criteria, completed both study periods, and had no compliance or assay issues.
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Subject analysis set title |
Enteric-coated microgranule rabeprazole sodium (Test)
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Evaluable population included all participants who satisfied all inclusion and none of the exclusion criteria, completed both study periods, and had no compliance or assay issues. Within 5 minutes of taking study drug, participants were asked to fill out a questionnaire regarding its palatability.
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End point title |
Mean Area Under the Concentration Curve from Time 0 to Time t (AUC)(0-t)) | ||||||||||||
End point description |
Blood samples were drawn at specific time points then analyzed for the amount of rabeprazole sodium in the plasma using a liquid chromatography/tandem mass spectrometry system (LC/MS/MS) and a validated method. The pharmacokinetic (PK) parameter, AUC(0-t), where ‘t’ represents the time of last quantifiable plasma concentration, was calculated using the trapezoidal rule and summarized using descriptive statistics. The average bioequivalence (BE) was used for testing bioequivalence of AUC.
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End point type |
Primary
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End point timeframe |
Day 1 of Period 1 and 2; Predose (-1 hour) and at 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 14, and 16 hours postdose.
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Statistical analysis title |
Statistical Analysis of AUC (0-t) | ||||||||||||
Statistical analysis description |
Per Food and Drug Administration (FDA) recommended criteria, the 90% confidence interval (CI) for the geometric Test/Reference mean had to be within the 80% to 125% interval in order to have a conclusion of average bioequivalence of the two formulas. Due to the nature of normal theory CIs, this is equivalent to performing two one-sided test of hypothesis at the 5% level of confidence.
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Comparison groups |
Enteric-coated microgranule rabeprazole sodium (Test) v Rabeprazole sodium (Reference)
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Number of subjects included in analysis |
31
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Analysis specification |
Pre-specified
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Analysis type |
equivalence [1] | ||||||||||||
P-value |
= 0.295 [2] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Ratio of Test/Reference | ||||||||||||
Point estimate |
93
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
81.63 | ||||||||||||
upper limit |
104.36 | ||||||||||||
Notes [1] - The bioequivalence of rabeprazole sodium tablet (Reference) and rabeprazole sodium enteric-coated microgranules (Test) was analyzed. [2] - Statistical tests were two-sided and at the significance alpha level of less than or equal to 0.05. |
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End point title |
Mean Log Transformed Values for AUC(0-t) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 1 of Period 1 and 2; Predose (-1 hour) and at 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 14, and 16 hours postdose
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Statistical analysis title |
Statistical Analysis of Log Transformed AUC(0-t) | ||||||||||||
Statistical analysis description |
Per Food and Drug Administration (FDA) recommended criteria, the 90% confidence interval (CI) for the geometric Test/Reference mean had to be within the 80% to 125% interval in order to have a conclusion of average bioequivalence of the two formulas. Due to the nature of normal theory CIs, this is equivalent to performing two one-sided test of hypothesis at the 5% level of confidence.
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Comparison groups |
Rabeprazole sodium (Reference) v Enteric-coated microgranule rabeprazole sodium (Test)
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Number of subjects included in analysis |
31
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Analysis specification |
Pre-specified
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Analysis type |
equivalence [3] | ||||||||||||
P-value |
= 0.3325 [4] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Ratio Test/Reference | ||||||||||||
Point estimate |
92.35
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
80.29 | ||||||||||||
upper limit |
106.23 | ||||||||||||
Notes [3] - The bioequivalence of rabeprazole sodium tablet (Reference) and rabeprazole sodium enteric-coated microgranules (Test) was analyzed. [4] - Statistical tests were two-sided and at the significance alpha level of less than or equal to 0.05. |
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End point title |
Mean Area Under the Concentration Curve from Time 0 to Infinity (AUC(0 - ∞)) | ||||||||||||
End point description |
Blood samples were drawn at specific time points then analyzed for the amount of rabeprazole sodium in the plasma using a liquid chromatography/tandem mass spectrometry system (LC/MS/MS) and a validated method. The PK parameter, AUC(0-∞), was determined, where AUC = AUC(0-t) + C(t)/λz and C(t) is the last measurable concentration and λz is the apparent terminal disposition rate constant. PK parameters were summarized using descriptive statistics. The average bioequivalence (BE) was used for testing bioequivalence of AUC. For this endpoint participants 11, 12, 14, and 15 for E3810 analyte were excluded due to missing or non-reportable PK parameters.
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End point type |
Primary
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End point timeframe |
Day 1 of Period 1 and 2; Predose (-1 hour) and at 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 14, and 16 hours postdose
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Notes [5] - Participants 11, 12, 14, and 15 were excluded due to missing or non-reportable PK parameters. [6] - Participants 11, 12, 14, and 15 were excluded due to missing or non-reportable PK parameters. |
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Statistical analysis title |
Statistical Analysis of AUC (0 - ∞) | ||||||||||||
Statistical analysis description |
Per Food and Drug Administration (FDA) recommended criteria, the 90% confidence interval (CI) for the geometric Test/Reference mean had to be within the 80% to 125% interval in order to have a conclusion of average bioequivalence of the two formulas. Due to the nature of normal theory CIs, this is equivalent to performing two one-sided test of hypothesis at the 5% level of confidence.
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Comparison groups |
Rabeprazole sodium (Reference) v Enteric-coated microgranule rabeprazole sodium (Test)
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Number of subjects included in analysis |
24
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Analysis specification |
Pre-specified
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Analysis type |
equivalence [7] | ||||||||||||
P-value |
= 0.2471 [8] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Ratio of Test/Reference | ||||||||||||
Point estimate |
91.71
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
79.48 | ||||||||||||
upper limit |
103.93 | ||||||||||||
Notes [7] - The bioequivalence of rabeprazole sodium tablet (Reference) and rabeprazole sodium enteric-coated microgranules (Test) was analyzed. [8] - Statistical tests were two-sided and at the significance alpha level of less than or equal to 0.05. |
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End point title |
Mean Maximum Drug Plasma Concentration (Cmax) | ||||||||||||
End point description |
Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve. The maximum observed plasma concentration of E3810 was obtained directly from the data, with and without interpolation. PK parameters were summarized using descriptive statistics. The average bioequivalence (BE) was used for testing bioequivalence of AUC.
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End point type |
Primary
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End point timeframe |
Day 1 of Period 1 and 2; Predose (-1 hour) and at 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 14, and 16 hours postdose.
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Statistical analysis title |
Statistical Analysis of Cmax | ||||||||||||
Statistical analysis description |
Per Food and Drug Administration (FDA) recommended criteria, the 90% confidence interval (CI) for the geometric Test/Reference mean had to be within the 80% to 125% interval in order to have a conclusion of average bioequivalence of the two formulas. Due to the nature of normal theory CIs, this is equivalent to performing two one-sided test of hypothesis at the 5% level of confidence.
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Comparison groups |
Rabeprazole sodium (Reference) v Enteric-coated microgranule rabeprazole sodium (Test)
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Number of subjects included in analysis |
31
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Analysis specification |
Pre-specified
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Analysis type |
equivalence [9] | ||||||||||||
P-value |
= 0.0017 [10] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Ratio of Test/Reference | ||||||||||||
Point estimate |
65.89
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
50.61 | ||||||||||||
upper limit |
81.17 | ||||||||||||
Notes [9] - The bioequivalence of rabeprazole sodium tablet (Reference) and rabeprazole sodium enteric-coated microgranules (Test) was analyzed. [10] - Statistical tests were two-sided and at the significance alpha level of less than or equal to 0.05. |
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End point title |
Mean Log Transformed Values for Cmax | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 1 of Period 1 and 2; Predose (-1 hour) and at 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 14, and 16 hours postdose
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Statistical analysis title |
Statistical Analysis for Log Cmax | ||||||||||||
Statistical analysis description |
Per Food and Drug Administration (FDA) recommended criteria, the 90% confidence interval (CI) for the geometric Test/Reference mean had to be within the 80% to 125% interval in order to have a conclusion of average bioequivalence of the two formulas. Due to the nature of normal theory CIs, this is equivalent to performing two one-sided test of hypothesis at the 5% level of confidence.
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Comparison groups |
Rabeprazole sodium (Reference) v Enteric-coated microgranule rabeprazole sodium (Test)
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Number of subjects included in analysis |
31
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Analysis specification |
Pre-specified
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Analysis type |
equivalence [11] | ||||||||||||
P-value |
= 0.0058 [12] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Ratio of Test/Reference | ||||||||||||
Point estimate |
64.77
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
51.28 | ||||||||||||
upper limit |
81.81 | ||||||||||||
Notes [11] - The bioequivalence of rabeprazole sodium tablet (Reference) and rabeprazole sodium enteric-coated microgranules (Test) was analyzed. [12] - Statistical tests were two-sided and at the significance alpha level of less than or equal to 0.05. |
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End point title |
Mean Elimination of Half-life during the Apparent Terminal Disposition Phase (t1/2λz) | ||||||||||||
End point description |
The elimination of half-life during the apparent terminal disposition phase was calculated as 0.693/λz. Participants 11, 12, 14, and 15 were excluded due to missing or non-reportable PK parameters.
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End point type |
Primary
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End point timeframe |
Day 1 of Period 1 and 2; Predose (-1 hour) and at 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 14, and 16 hours postdose
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Statistical analysis title |
Statistical Analysis of Elimination of Half-life | ||||||||||||
Statistical analysis description |
The bioequivalence of rabeprazole sodium tablet (Reference) and rabeprazole sodium enteric-coated microgranules (Test) was analyzed.
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Comparison groups |
Rabeprazole sodium (Reference) v Enteric-coated microgranule rabeprazole sodium (Test)
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Number of subjects included in analysis |
24
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.9797 [13] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Notes [13] - Statistical tests were two-sided and at the significance alpha level of less than or equal to 0.05. |
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End point title |
Mean Time of Maximum Observed Plasma Concentration (Tmax) | ||||||||||||
End point description |
Time of maximum observed plasma concentration of E3810 was obtained directly from the data, with and without interpolation. Evaluable population was used and included all participants who satisfied all inclusion and none of the exclusion criteria, completed both study periods, and had no compliance or assay issues.
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End point type |
Primary
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End point timeframe |
Day 1 of Period 1 and 2; Predose (-1 hour) and at 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 14, and 16 hours postdose.
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Statistical analysis title |
Statistical Analysis of Tmax | ||||||||||||
Comparison groups |
Enteric-coated microgranule rabeprazole sodium (Test) v Rabeprazole sodium (Reference)
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Number of subjects included in analysis |
31
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Analysis specification |
Pre-specified
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Analysis type |
equivalence [14] | ||||||||||||
P-value |
= 0 [15] | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Notes [14] - The bioequivalence of rabeprazole sodium tablet (Reference) and rabeprazole sodium enteric-coated microgranules (Test) was analyzed. [15] - Statistical tests were two-sided and at the significance alpha level of less than or equal to 0.05. |
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End point title |
Overall Acceptance of Palatability of Enteric-Coated Microgranule Rabeprazole sodium | ||||||||||||||||||
End point description |
The palatability questionnaire was administered within 5 minutes of receiving the enteric-coated microgranule formulation of rabeprazole sodium. The parameters of 'taste', 'smell', 'texture (smoothness)', 'after taste', and 'overall acceptance' were investigated. The final analysis of palatability for all categories was expressed as the percentage of participants who indicated a response of “like”, “dislike”, “like very much”, and “neither like nor dislike”. Only participants who received the enteric-coated microgranule formulation of rabeprazole sodium oral suspension.
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End point type |
Secondary
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End point timeframe |
Within 5 minutes of receiving enteric-coated microgranule formulation of rabeprazole sodium
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No statistical analyses for this end point |
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End point title |
Palatability Taste Test Ratings of Enteric-Coated Microgranule Rabeprazole sodium | ||||||||||||||||
End point description |
The palatability questionnaire was administered within 5 minutes of receiving the enteric-coated microgranule formulation of rabeprazole sodium. The parameters of 'taste', 'smell', 'texture (smoothness)', 'after taste', and 'overall acceptance' were investigated. The final analysis of palatability for all categories was expressed as the percentage of participants who indicated a response of “like”, “dislike”, “like very much”, and “neither like nor dislike”. Only participants who received the enteric-coated microgranule formulation of rabeprazole sodium oral suspension.
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End point type |
Secondary
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End point timeframe |
Within 5 minutes of receiving enteric-coated microgranule formulation of rabeprazole sodium
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No statistical analyses for this end point |
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End point title |
Palatability Texture (Smoothness) Test Ratings of Enteric-Coated Microgranule Rabeprazole sodium | ||||||||||||||||
End point description |
The palatability questionnaire was administered within 5 minutes of receiving the enteric-coated microgranule formulation of rabeprazole sodium. The parameters of 'taste', 'smell', 'texture (smoothness)', 'after taste', and 'overall acceptance' were investigated. The final analysis of palatability for all categories was expressed as the percentage of participants who indicated a response of “like”, “dislike”, “like very much”, and “neither like nor dislike”. Only participants who received the enteric-coated microgranule formulation of rabeprazole sodium oral suspension.
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End point type |
Secondary
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End point timeframe |
Within 5 minutes of receiving enteric-coated microgranule formulation of rabeprazole sodium
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No statistical analyses for this end point |
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End point title |
Palatability After Taste Test Ratings of Enteric-Coated Microgranule Rabeprazole sodium | ||||||||||||||||
End point description |
The palatability questionnaire was administered within 5 minutes of receiving the enteric-coated microgranule formulation of rabeprazole sodium. The parameters of 'taste', 'smell', 'texture (smoothness)', 'after taste', and 'overall acceptance' were investigated. The final analysis of palatability for all categories was expressed as the percentage of participants who indicated a response of “like”, “dislike”, “like very much”, and “neither like nor dislike”. Only participants who received the enteric-coated microgranule formulation of rabeprazole sodium oral suspension.
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End point type |
Secondary
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End point timeframe |
Within 5 minutes of receiving enteric-coated microgranule formulation of rabeprazole sodium
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No statistical analyses for this end point |
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End point title |
Palatability Smell Test Ratings of Enteric-Coated Microgranule Rabeprazole sodium | ||||||||||||||||
End point description |
The palatability questionnaire was administered within 5 minutes of receiving the enteric-coated microgranule formulation of rabeprazole sodium. The parameters of 'taste', 'smell', 'texture (smoothness)', 'after taste', and 'overall acceptance' were investigated. The final analysis of palatability for all categories was expressed as the percentage of participants who indicated a response of “like”, “dislike”, “like very much”, and “neither like nor dislike”. Only participants who received the enteric-coated microgranule formulation of rabeprazole sodium oral suspension.
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End point type |
Secondary
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End point timeframe |
Within 5 minutes of receiving enteric-coated microgranule formulation of rabeprazole sodium
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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 |
Adverse events were collected from the day of signed informed consent to the discharge study visit, or for approximately 12 days.
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Adverse event reporting additional description |
Adverse events were recorded as treatment-emergent signs and symptoms (TESS), which is the same as treatment-emergent adverse events for this study. The Safety Population included all participants who took at least one dose of either formulation of rabeprazole sodium.
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Assessment type |
Systematic | |||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||
Dictionary version |
7.1
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Reporting groups
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Reporting group title |
Rabeprazole sodium tablet
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Reporting group description |
Participants were administered 10-mg rabeprazole tablet followed by a 1-week washout period after which they were administered 10-mg rabeprazole microgranule formulation. | |||||||||||||||||||||
Reporting group title |
Rabeprazole sodium (microgranule formula)
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Reporting group description |
Participants were administered 10-mg rabeprazole microgranule formulation followed by a 1-week washout period after which they were administered 10-mg rabeprazole tablet. | |||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |