Clinical Trial Results:
MK-0518B Food Effect Study
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Summary
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EudraCT number |
2014-004766-15 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
02 Nov 2012
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Mar 2016
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First version publication date |
19 Jul 2015
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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 |
MK-0518B-254
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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 |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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-001442-PIP01-13 | ||
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 |
02 Nov 2012
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Nov 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Nov 2012
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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 |
This study aimed to assess the effect of a high-fat meal on the in vivo performance of Raltegravir/lamivudine (MK-0518B) 300 mg/150 mg Fixed-Dose Combination (FDC) tablets after a single-dose in healthy participants.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Oct 2012
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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 |
Canada: 20
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Worldwide total number of subjects |
20
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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) |
20
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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 |
- | ||||||
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Pre-assignment
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Screening details |
Healthy, non-smoking, male and female volunteers from 18 to 55 years of age, with a Body Mass Index (BMI) ≥19.0 and ≤ 30.0 kg/m^2 were enrolled in this study. | ||||||
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Period 1
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Period 1 title |
Crossover Period 1
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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All treated participants | ||||||
Arm description |
Participants were assigned to one of the following two crossover treatment sequences: Period 1 was an overnight fast of at least 10 hours prior to drug administration; followed by Period 2 with a standardized high fat, high calorie breakfast 30 minutes prior to drug administration; or vice versa. In both periods participants were given a single oral treatment of raltegravir 300 mg/ lamivudine 150 mg fixed-dose combination (FDC) tablet. Period 1 was separated from Period 2 by a 7 day washout. The population analysed was all participants who received at least one administration of study treatment. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Raltegravir/lamivudine 300 mg/150 mg FDC tablets
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Investigational medicinal product code |
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Other name |
MK-0518B
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
A single Raltegravir/lamivudine 300 mg/150 mg FDC tablet was administered orally, at the start of each crossover period.
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Period 2
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Period 2 title |
Crossover Period 2
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Is this the baseline period? |
No | ||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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All treated participants | ||||||
Arm description |
Participants were assigned to one of the following two crossover treatment sequences: Period 1 was an overnight fast of at least 10 hours prior to drug administration; followed by Period 2 with a standardized high fat, high calorie breakfast 30 minutes prior to drug administration; or vice versa. In both periods participants were given a single oral treatment of raltegravir 300 mg/ lamivudine 150 mg fixed-dose combination (FDC) tablet. Period 1 was separated from Period 2 by a 7 day washout. The population analysed was all participants who received at least one administration of study treatment. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Raltegravir/lamivudine 300 mg/150 mg FDC tablets
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Investigational medicinal product code |
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Other name |
MK-0518B
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
A single Raltegravir/lamivudine 300 mg/150 mg FDC tablet was administered orally, at the start of each crossover period.
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Baseline characteristics reporting groups
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Reporting group title |
Crossover Period 1
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Reporting group description |
Participants were assigned to one of the following two crossover treatment sequences: Period 1 was an overnight fast of at least 10 hours prior to drug administration; followed by Period 2 with a standardized high fat, high calorie breakfast 30 minutes prior to drug administration; or vice versa. In both periods participants were given a single oral treatment of raltegravir 300 mg/ lamivudine 150 mg fixed-dose combination (FDC) tablet. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
All treated participants
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Reporting group description |
Participants were assigned to one of the following two crossover treatment sequences: Period 1 was an overnight fast of at least 10 hours prior to drug administration; followed by Period 2 with a standardized high fat, high calorie breakfast 30 minutes prior to drug administration; or vice versa. In both periods participants were given a single oral treatment of raltegravir 300 mg/ lamivudine 150 mg fixed-dose combination (FDC) tablet. Period 1 was separated from Period 2 by a 7 day washout. The population analysed was all participants who received at least one administration of study treatment. | ||
Reporting group title |
All treated participants
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Reporting group description |
Participants were assigned to one of the following two crossover treatment sequences: Period 1 was an overnight fast of at least 10 hours prior to drug administration; followed by Period 2 with a standardized high fat, high calorie breakfast 30 minutes prior to drug administration; or vice versa. In both periods participants were given a single oral treatment of raltegravir 300 mg/ lamivudine 150 mg fixed-dose combination (FDC) tablet. Period 1 was separated from Period 2 by a 7 day washout. The population analysed was all participants who received at least one administration of study treatment. | ||
Subject analysis set title |
Fasted + FDC Treatment
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Participants had a 10 hour overnight fast prior to treatment with a single FDC tablet containing raltegravir and lamivudine. The pharmacokinetic population analyzed had a sufficient set of samples in at least one study period, to provide enough data to estimate a particular endpoint.
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Subject analysis set title |
High Fat Meal + FDC Treatment
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Participants had a high fat, high calorie breakfast 30 minutes prior to treatment with a single FDC tablet containing raltegravir and lamivudine. The pharmacokinetic population analyzed had a sufficient set of samples in at least one study period, to provide enough data to estimate a particular endpoint..
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End point title |
Area under the plasma concentration time curve from time 0 to last time with quantifiable drug (AUC 0-t) of Raltegravir and Lamivudine | ||||||||||||||||||
End point description |
Participants were treated with a single FDC tablet, then blood samples were obtained at the following time-points: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose in order to determine the AUC 0-t of raltegravir and lamivudine.
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End point type |
Primary
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End point timeframe |
Pre-dose, and from 0.5 to 48 hours post-dose
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Statistical analysis title |
Geom. Mean Ratio (GMR) % Fasted vs Meal - Ralt | ||||||||||||||||||
Statistical analysis description |
Based on log-transformed data, and using a linear mixed effects model. The correct number of participants in this analysis is not 40, but 20: the number of participants in this analysis who were fasted was 20, and the same 20 participants received a high fat meal.
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Comparison groups |
Fasted + FDC Treatment v High Fat Meal + FDC Treatment
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||||||||
Method |
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Parameter type |
GMR % | ||||||||||||||||||
Point estimate |
94.47
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Confidence interval |
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level |
90% | ||||||||||||||||||
sides |
2-sided
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lower limit |
83.37 | ||||||||||||||||||
upper limit |
107.05 | ||||||||||||||||||
| Notes [1] - GMR % (Fed/Fasted) was estimated; did not include any pre-specified bounds. |
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Statistical analysis title |
GMR % Fasted vs Meal - Lami | ||||||||||||||||||
Statistical analysis description |
Based on log-transformed data, and using a linear mixed effects model. The correct number of participants in this analysis is not 40, but 20: the number of participants in this analysis who were fasted was 20, and the same 20 participants received a high fat meal.
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Comparison groups |
Fasted + FDC Treatment v High Fat Meal + FDC Treatment
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
other [2] | ||||||||||||||||||
Method |
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Parameter type |
GMR % | ||||||||||||||||||
Point estimate |
92.45
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Confidence interval |
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level |
90% | ||||||||||||||||||
sides |
2-sided
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lower limit |
87.23 | ||||||||||||||||||
upper limit |
97.98 | ||||||||||||||||||
| Notes [2] - GMR % (Fed/Fasted) was estimated; did not include any pre-specified bounds. |
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End point title |
Area under the plasma concentration time curve from time 0 to infinity (AUC 0-inf) of Raltegravir and Lamivudine | ||||||||||||||||||
End point description |
Participants were treated with a single FDC tablet, then blood samples were obtained at the following time-points: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose in order to determine the AUC 0-inf of raltegravir and lamivudine.
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End point type |
Primary
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End point timeframe |
Pre-dose, and 0.5 to 48 hours post-dose
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Statistical analysis title |
GMR % Fasted vs Meal - Ralt | ||||||||||||||||||
Statistical analysis description |
Based on log-transformed data, and using a linear mixed effects model. The correct number of participants in this analysis is not 40, but 20: the number of participants in this analysis who were fasted was 20, and the same 20 participants received a high fat meal.
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Comparison groups |
High Fat Meal + FDC Treatment v Fasted + FDC Treatment
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
other [3] | ||||||||||||||||||
Method |
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Parameter type |
GMR % | ||||||||||||||||||
Point estimate |
94.22
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Confidence interval |
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level |
90% | ||||||||||||||||||
sides |
2-sided
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lower limit |
82.93 | ||||||||||||||||||
upper limit |
107.05 | ||||||||||||||||||
| Notes [3] - GMR % (Fed/Fasted) was estimated; did not include any pre-specified bounds. |
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Statistical analysis title |
GMR % Fasted vs Meal - Lami | ||||||||||||||||||
Statistical analysis description |
Based on log-transformed data, and using a linear mixed effects model. The correct number of participants in this analysis is not 40, but 20: the number of participants in this analysis who were fasted was 20, and the same 20 participants received a high fat meal.
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Comparison groups |
Fasted + FDC Treatment v High Fat Meal + FDC Treatment
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
other [4] | ||||||||||||||||||
Method |
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Parameter type |
GMR % | ||||||||||||||||||
Point estimate |
92.43
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Confidence interval |
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level |
90% | ||||||||||||||||||
sides |
2-sided
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lower limit |
87.51 | ||||||||||||||||||
upper limit |
97.63 | ||||||||||||||||||
| Notes [4] - GMR % (Fed/Fasted) was estimated; did not include any pre-specified bounds. |
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End point title |
Maximum plasma concentration (Cmax) of Raltegravir and Lamivudine | ||||||||||||||||||
End point description |
Participants were treated with a single FDC tablet, then blood samples were obtained at the following time-points: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose in order to determine the Cmax of raltegravir and lamivudine.
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End point type |
Primary
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End point timeframe |
Pre-dose, and 0.5 to 48 hours post-dose
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Statistical analysis title |
GMR % Fasted vs Meal - Ralt | ||||||||||||||||||
Statistical analysis description |
Based on log-transformed data, and using a linear mixed effects model. The correct number of participants in this analysis is not 40, but 20: the number of participants in this analysis who were fasted was 20, and the same 20 participants received a high fat meal.
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Comparison groups |
Fasted + FDC Treatment v High Fat Meal + FDC Treatment
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
other [5] | ||||||||||||||||||
Method |
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Parameter type |
GMR % | ||||||||||||||||||
Point estimate |
76.99
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Confidence interval |
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level |
90% | ||||||||||||||||||
sides |
2-sided
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lower limit |
55.16 | ||||||||||||||||||
upper limit |
107.46 | ||||||||||||||||||
| Notes [5] - GMR % (Fed/Fasted) was estimated; did not include any pre-specified bounds. |
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Statistical analysis title |
GMR % Fasted vs Meal - Lami | ||||||||||||||||||
Statistical analysis description |
Based on log-transformed data, and using a linear mixed effects model. The correct number of participants in this analysis is not 40, but 20: the number of participants in this analysis who were fasted was 20, and the same 20 participants received a high fat meal.
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Comparison groups |
Fasted + FDC Treatment v High Fat Meal + FDC Treatment
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
other [6] | ||||||||||||||||||
Method |
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Parameter type |
GMR % | ||||||||||||||||||
Point estimate |
79.43
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Confidence interval |
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level |
90% | ||||||||||||||||||
sides |
2-sided
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lower limit |
70.73 | ||||||||||||||||||
upper limit |
89.2 | ||||||||||||||||||
| Notes [6] - GMR % (Fed/Fasted) was estimated; did not include any pre-specified bounds. |
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End point title |
Plasma concentration at 12 hours post-dose (C12hr) of Raltegravir and Lamivudine | ||||||||||||||||||
End point description |
Participants were treated with a single FDC tablet, then blood samples were obtained at 12 hours post-dose in order to determine the C12hr of raltegravir and lamivudine.
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End point type |
Primary
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End point timeframe |
12 hours post-dose
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Statistical analysis title |
GMR % Fasted vs Meal - Ralt | ||||||||||||||||||
Statistical analysis description |
Based on log-transformed data, and using a linear mixed effects model. The correct number of participants in this analysis is not 40, but 20: the number of participants in this analysis who were fasted was 20, and the same 20 participants received a high fat meal.
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Comparison groups |
Fasted + FDC Treatment v High Fat Meal + FDC Treatment
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
other [7] | ||||||||||||||||||
Method |
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Parameter type |
GMR % | ||||||||||||||||||
Point estimate |
120.14
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Confidence interval |
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level |
90% | ||||||||||||||||||
sides |
2-sided
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lower limit |
89.48 | ||||||||||||||||||
upper limit |
161.3 | ||||||||||||||||||
| Notes [7] - GMR % (Fed/Fasted) was estimated; did not include any pre-specified bounds. |
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Statistical analysis title |
GMR Fasted vs Meal - Lami | ||||||||||||||||||
Statistical analysis description |
Based on log-transformed data, and using a linear mixed effects model. The correct number of participants in this analysis is not 40, but 20: the number of participants in this analysis who were fasted was 20, and the same 20 participants received a high fat meal.
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Comparison groups |
Fasted + FDC Treatment v High Fat Meal + FDC Treatment
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
other [8] | ||||||||||||||||||
Method |
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Parameter type |
GMR % | ||||||||||||||||||
Point estimate |
152.62
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Confidence interval |
|||||||||||||||||||
level |
90% | ||||||||||||||||||
sides |
2-sided
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lower limit |
134.47 | ||||||||||||||||||
upper limit |
173.22 | ||||||||||||||||||
| Notes [8] - GMR % (Fed/Fasted) was estimated; did not include any pre-specified bounds. |
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End point title |
Time to maximum plasma concentration (Tmax) of Raltegravir and Lamivudine [9] | ||||||||||||||||||
End point description |
Participants were treated with a single FDC tablet, then blood samples were obtained at the following time-points: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose in order to determine the Tmax of raltegravir and lamivudine.
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End point type |
Primary
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End point timeframe |
Pre-dose, and 0.5 to 48 hours post-dose
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| Notes [9] - 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 summary statistics are provided. Statistical comparisons between arms were neither planned nor performed for this primary endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Apparent elimination half-life (t1/2) of Raltegravir and Lamivudine [10] | ||||||||||||||||||
End point description |
Participants were treated with a single FDC tablet, then blood samples were obtained at the following time-points: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose in order to determine the t1/2 of raltegravir and lamivudine.
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End point type |
Primary
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End point timeframe |
Pre-dose, and 0.5 to 48 hours post-dose
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| Notes [10] - 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 summary statistics are provided. Statistical comparisons between arms were neither planned nor performed for this primary endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Apparent terminal first order elimination rate constant (Kel) of Raltegravir and Lamivudine [11] | ||||||||||||||||||
End point description |
Participants were treated with a single FDC tablet, then blood samples were obtained at the following time-points: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose in order to determine the Kel of raltegravir and lamivudine.
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End point type |
Primary
|
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End point timeframe |
Pre-dose, and 0.5 to 48 hours post-dose
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| Notes [11] - 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 summary statistics are provided. Statistical comparisons between arms were neither planned nor performed for this primary endpoint. |
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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 |
Up to 14 days after receiving the last treatment in Period 2 (up to Day 25).
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Adverse event reporting additional description |
Period 1 was a 10 hour overnight fast prior to drug; Period 2 was a high fat, high calorie breakfast 30 minutes prior to drug; or vice versa. Participants were given a single FDC tablet containing raltegravir and lamivudine in both periods. The population analysed was all participants who received at least one administration of study treatment.
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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 |
15.1
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Reporting groups
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Reporting group title |
Fasted + FDC Treatment
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Reporting group description |
Participants had a 10 hour overnight fast prior to treatment with a single FDC tablet containing raltegravir and lamivudine. The population analysed was all participants who received at least one administration of study treatment. | ||||||||||||||||||||||||||||||
Reporting group title |
High Fat Meal + FDC Treatment
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Reporting group description |
Participants had a high fat, high calorie breakfast 30 minutes prior to treatment with a single FDC tablet containing raltegravir and lamivudine. The population analysed was all participants who received at least one administration of study treatment. | ||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||
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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 | |||
