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    Clinical Trial Results:
    MK-0518B (EU Sourced Lamivudine) Bioequivalence Study

    Summary
    EudraCT number
    		 2014-004767-21
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    22 Oct 2012

    Results information
    Results version number
    		 v2(current)
    This version publication date
    09 Apr 2016
    First version publication date
    19 Jul 2015
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    0518B-258
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001442-PIP01-13
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Oct 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Oct 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study aimed to evaluate the comparative bioavailability between Raltegravir/Lamivudine (MK-0518B) 300 mg/150 mg fixed dose combination (FDC) tablets, with a 400 mg Raltegravir tablet co-administered with a 150 mg Lamivudine tablet, after a single-dose administration in healthy participants under fasting conditions. The primary hypotheses were as follows: for Raltegravir the 90% confidence intervals of the geometric mean ratio (GMR, FDC/separate tablets) of area under the concentration curve from time 0 to the time of last measurable analyte (AUC0-t) should be between 80.00 and 125.00%; for Raltegravir the 90% confidence intervals of the geometric mean ratio (GMR, FDC/separate tablets) of the plasma concentration at 12 hours post administration (C12hr) should be between 80.00 and 200.00%; and for Lamivudine the 90% confidence intervals of the geometric mean ratio (GMR, FDC/separate tablets) of AUC0-t and the maximum plasma concentration (Cmax) should be between 80.00 and 125.00%.
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 108
    Worldwide total number of subjects
    108
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    108
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Healthy, non-smoking, male and female volunteers from 18 to 55 years of age, with a Body Mass Index (BMI) ≥18.5 and ≤ 30.0 kg/m^2 were enrolled in this study.

    Period 1
    Period 1 title
    Crossover Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All treated participants
    Arm description
    		 Participants were assigned to one of the following two crossover treatment sequences: one FDC tablet containing both Raltegravir and Lamivudine in Period 1; followed by individual Raltegravir and Lamivudine tablets in Period 2; or vice versa. Period 1 was separated from Period 2 by a minimum of 7 days 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
    Investigational medicinal product code
    Other name
    MK-0518B
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single Raltegravir/lamivudine 300 mg/150 mg FDC tablet was administered orally, under fasting conditions at the start of each crossover period.

    Investigational medicinal product name
    Lamivudine
    Investigational medicinal product code
    Other name
    Epivir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single Lamivudine 150 mg tablet was administered orally, under fasting conditions at the start of each crossover period.

    Investigational medicinal product name
    Raltegravir
    Investigational medicinal product code
    Other name
    Isentress
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single Raltegravir 400 mg tablet was administered orally, under fasting conditions at the start of each crossover period.

    Number of subjects in period 1
    		All treated participants
    Started
    108
    Completed
    103
    Not completed
    5
         Consent withdrawn by subject
    4
         Dismissed
    1
    Period 2
    Period 2 title
    Crossover Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All treated participants
    Arm description
    		 Participants were assigned to one of the following two crossover treatment sequences: one FDC tablet containing both Raltegravir and Lamivudine in Period 1; followed by individual Raltegravir and Lamivudine tablets in Period 2; or vice versa. Period 1 was separated from Period 2 by a minimum of 7 days 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
    Investigational medicinal product code
    Other name
    MK-0518B
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single Raltegravir/lamivudine 300 mg/150 mg FDC tablet was administered orally, under fasting conditions at the start of each crossover period.

    Investigational medicinal product name
    Lamivudine
    Investigational medicinal product code
    Other name
    Epivir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single Lamivudine 150 mg tablet was administered orally, under fasting conditions at the start of each crossover period.

    Investigational medicinal product name
    Raltegravir
    Investigational medicinal product code
    Other name
    Isentress
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single Raltegravir 400 mg tablet was administered orally, under fasting conditions at the start of each crossover period.

    Number of subjects in period 2
    		All treated participants
    Started
    103
    Completed
    103

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Crossover Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Crossover Period 1 Total
    Number of subjects
    		 108 108
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35 ( 10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 55 55
        Male
    		 53 53

    End points

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    End points reporting groups
    Reporting group title
    All treated participants
    Reporting group description
    		 Participants were assigned to one of the following two crossover treatment sequences: one FDC tablet containing both Raltegravir and Lamivudine in Period 1; followed by individual Raltegravir and Lamivudine tablets in Period 2; or vice versa. Period 1 was separated from Period 2 by a minimum of 7 days washout. The population analysed was all participants who received at least one administration of study treatment.
    Reporting group title
    All treated participants
    Reporting group description
    		 Participants were assigned to one of the following two crossover treatment sequences: one FDC tablet containing both Raltegravir and Lamivudine in Period 1; followed by individual Raltegravir and Lamivudine tablets in Period 2; or vice versa. Period 1 was separated from Period 2 by a minimum of 7 days washout. The population analysed was all participants who received at least one administration of study treatment.

    Subject analysis set title
    Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants were treated with one FDC tablet containing both 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.

    Subject analysis set title
    Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants were treated with individual Raltegravir and Lamivudine tablets.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.

    Primary: Area under the plasma concentration time curve from time 0 to last time with quantifiable drug (AUC 0-t) of Raltegravir and Lamivudine

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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 or two separate tablets. 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.
    End point type
    Primary
    End point timeframe
    Pre-dose, and from 0.5 to 48 hours post-dose
    End point values
    		 Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Number of subjects analysed
    106
    103
    Units: hr.ng./mL
    geometric mean (confidence interval 95%)
        Raltegravir
    8706.03 (8142.17 to 9308.93)
    8622.42 (7628.48 to 9745.86)
        Lamivudine
    5946.8 (5677.7 to 6228.7)
    6049.9 (5796 to 6314.9)
    Statistical analysis title
    		 Geom. Mean Ratio (GMR) % FDC vs Separate - Ralt
    Statistical analysis description
    Based on log-transformed data, and using a linear mixed effects model. The linear mixed-effect model contained period and treatment as fixed effects. An unstructured covariance matrix was used to allow for unequal treatment variances and to model the correlation between the two treatment measurements within each participant. The number of participants treated with a single FDC tablet = 106; number treated with two separate tablets = 103.
    Comparison groups
    Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet v Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Number of subjects included in analysis
    209
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    Method
    Parameter type
    		 GMR %
    Point estimate
    100.97
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 92.46
         upper limit
    		 110.27
    Notes
    [1] - The 90% confidence interval (CI) of the GMR % (FDC/Individual tablets) should be between 80 and 125%.
    Statistical analysis title
    		 GMR % FDC vs Separate - Lami
    Statistical analysis description
    Based on log-transformed data, and using a linear mixed effects model. The linear mixed-effect model contained period and treatment as fixed effects. An unstructured covariance matrix was used to allow for unequal treatment variances and to model the correlation between the two treatment measurements within each participant. The number of participants treated with a single FDC tablet = 106; number treated with two separate tablets = 103.
    Comparison groups
    Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet v Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Number of subjects included in analysis
    209
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    Method
    Parameter type
    		 GMR %
    Point estimate
    98.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 96.03
         upper limit
    		 100.62
    Notes
    [2] - The 90% CI of the GMR % (FDC/Individual tablets) should be between 80 and 125%

    Primary: Area under the plasma concentration time curve from time 0 to infinity (AUC 0-inf) of Raltegravir and Lamivudine

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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 or two separate tablets. 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.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 0.5 to 48 hours post-dose
    End point values
    		 Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Number of subjects analysed
    106
    102
    Units: hr.ng./mL
    geometric mean (confidence interval 95%)
        Raltegravir (n = 103, 98)
    8852.32 (8267.17 to 9478.89)
    9019.93 (7921.1 to 10271.19)
        Lamivudine (n = 106, 102)
    6104 (5833.4 to 6387.2)
    6201.2 (5947.4 to 6465.8)
    Statistical analysis title
    		 GMR % one FDC vs two separate tablets - Ralt
    Statistical analysis description
    Based on log-transformed data, and using a linear mixed effects model. The linear mixed-effect model contained period and treatment as fixed effects. An unstructured covariance matrix was used to allow for unequal treatment variances and to model the correlation between the two treatment measurements within each participant. The number of participants treated with a single FDC tablet = 106; number treated with two separate tablets = 102.
    Comparison groups
    Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet v Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    Method
    Parameter type
    		 GMR %
    Point estimate
    98.14
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 89.48
         upper limit
    		 107.65
    Notes
    [3] - The 90% CI of the GMR % (FDC/Individual tablets) is presented.
    Statistical analysis title
    		 GMR % one FDC vs two separate tablets - Lami
    Statistical analysis description
    Based on log-transformed data, and using a linear mixed effects model. The linear mixed-effect model contained period and treatment as fixed effects. An unstructured covariance matrix was used to allow for unequal treatment variances and to model the correlation between the two treatment measurements within each participant. The number of participants treated with a single FDC tablet = 106; number treated with two separate tablets = 102.
    Comparison groups
    Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet v Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [4]
    Method
    Parameter type
    		 GMR %
    Point estimate
    98.43
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 96.32
         upper limit
    		 100.59
    Notes
    [4] - The 90% CI of the GMR % (FDC/Individual tablets) is presented.

    Primary: Plasma concentration at 12 hours post-dose (C12hr) of Raltegravir

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    End point title
    		 Plasma concentration at 12 hours post-dose (C12hr) of Raltegravir
    End point description
    Participants were treated with a single FDC tablet or two separate tablets. Blood samples were obtained at 12 hours post-dose in order to determine the C12hr of raltegravir.
    End point type
    Primary
    End point timeframe
    12 hours post-dose
    End point values
    		 Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Number of subjects analysed
    106
    103
    Units: ng/mL
        geometric mean (confidence interval 95%)
    36.55 (33 to 40.49)
    42.94 (38.63 to 47.73)
    Statistical analysis title
    		 GMR % one FDC vs two separate tablets - Ralt
    Statistical analysis description
    Based on log-transformed data, and using a linear mixed effects model. The linear mixed-effect model contained period and treatment as fixed effects. An unstructured covariance matrix was used to allow for unequal treatment variances and to model the correlation between the two treatment measurements within each participant. The number of participants treated with a single FDC tablet = 106; number treated with two separate tablets = 103.
    Comparison groups
    Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet v Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Number of subjects included in analysis
    209
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [5]
    Method
    Parameter type
    		 GMR %
    Point estimate
    85.12
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 78.69
         upper limit
    		 92.07
    Notes
    [5] - The 90% CI of the GMR % (FDC/Individual tablets) should be between 80 and 200%.

    Primary: Maximum plasma concentration (Cmax) of Lamivudine

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    End point title
    		 Maximum plasma concentration (Cmax) of Lamivudine
    End point description
    Participants were treated with a single FDC tablet or two separate tablets. 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 lamivudine.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 0.5 to 48 hours post-dose
    End point values
    		 Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Number of subjects analysed
    106
    103
    Units: ng/mL
        geometric mean (confidence interval 95%)
    1241.2 (1167.8 to 1319.2)
    1226.3 (1159.4 to 1297)
    Statistical analysis title
    		 GMR % one FDC vs two separate tablets - Lami
    Statistical analysis description
    Based on log-transformed data, and using a linear mixed effects model. The linear mixed-effect model contained period and treatment as fixed effects. An unstructured covariance matrix was used to allow for unequal treatment variances and to model the correlation between the two treatment measurements within each participant. The number of participants treated with a single FDC tablet = 106; number treated with two separate tablets = 103.
    Comparison groups
    Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet v Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Number of subjects included in analysis
    209
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [6]
    Method
    Parameter type
    		 GMR %
    Point estimate
    101.22
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 97.19
         upper limit
    		 105.41
    Notes
    [6] - The 90% CI of the GMR % (FDC/Individual tablets) should be between 80 and 125%

    Primary: Time to maximum plasma concentration (Tmax) of Raltegravir and Lamivudine

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    End point title
    		 Time to maximum plasma concentration (Tmax) of Raltegravir and Lamivudine [7]
    End point description
    Participants were treated with a single FDC tablet or two separate tablets. 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.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 0.5 to 48 hours post-dose
    Notes
    [7] - 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.
    End point values
    		 Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Number of subjects analysed
    106
    103
    Units: hrs.
    median (full range (min-max))
        Raltegravir
    1 (0.5 to 4)
    2 (0.5 to 6)
        Lamivudine
    2 (0.5 to 4)
    1 (0.5 to 4)
    No statistical analyses for this end point

    Primary: Apparent elimination half-life (t1/2) of Raltegravir and Lamivudine

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    End point title
    		 Apparent elimination half-life (t1/2) of Raltegravir and Lamivudine [8]
    End point description
    Participants were treated with a single FDC tablet or two separate tablets. 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.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 0.5 to 48 hours post-dose
    Notes
    [8] - 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.
    End point values
    		 Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Number of subjects analysed
    106
    102
    Units: hrs.
    geometric mean (geometric coefficient of variation)
        Raltegravir (n = 103, 98)
    11.2 ( 69.5 )
    12.1 ( 69.4 )
        Lamivudine (n = 106, 102)
    7.4 ( 57.3 )
    7.5 ( 58.5 )
    No statistical analyses for this end point

    Primary: Apparent terminal first order elimination rate constant (Kel) of Raltegravir and Lamivudine

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    End point title
    		 Apparent terminal first order elimination rate constant (Kel) of Raltegravir and Lamivudine [9]
    End point description
    Participants were treated with a single FDC tablet or two separate tablets. 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.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 0.5 to 48 hours post-dose
    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.
    End point values
    		 Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Number of subjects analysed
    106
    102
    Units: 1/hr.
    arithmetic mean (standard deviation)
        Raltegravir (n = 103, 98)
    0.073 ( 0.0391 )
    0.067 ( 0.0349 )
        Lamivudine (n = 106, 102)
    0.1052 ( 0.0429 )
    0.1037 ( 0.0403 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 14 days after receiving the last treatment
    Adverse event reporting additional description
    Participants were assigned to one of the following two crossover treatment sequences: one FDC tablet containing both Raltegravir and Lamivudine in Period 1; followed by individual Raltegravir and Lamivudine tablets in Period 2; or vice versa. The population analysed was all participants who received at least one administration of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet
    Reporting group description
    		 Participants who received a single Raltegravir/lamivudine 300 mg/150 mg FDC tablet during each treatment period.

    Reporting group title
    Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Reporting group description
    		 Participants who received separate Raltegravir 400 mg and Lamivudine 150 mg tablets during each treatment period.

    Serious adverse events
    		 Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 104 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Single Raltegravir/lamivudine 300 mg/150 mg FDC tablet Separate Raltegravir 400 mg and Lamivudine 150 mg tablets
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 107 (11.21%)
    10 / 104 (9.62%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 107 (11.21%)
    10 / 104 (9.62%)
         occurrences all number
    12
    12

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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
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