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    Clinical Trial Results:
    An Ascending Bioavailability of a New Oral Suspension of E3810

    Summary
    EudraCT number
    		 2016-001896-63
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    23 Jul 2005

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jul 2016
    First version publication date
    28 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    E3810-A001-015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eisai Medical Research Inc.
    Sponsor organisation address
    100 Tice Boulevard, Woodcliff Lake, United States, 07677
    Public contact
    Eisai Medical Information, Eisai Medical Research Inc., 1 8882472378, esi_medinfo@eisai.com
    Scientific contact
    Eisai Medical Information, Eisai Medical Research Inc., 1 8882472378, esi_medinfo@eisai.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000055-PIP01-07
    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
    23 Jul 2005
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2005
    Was the trial ended prematurely?
    No
    General information about the trial
    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.
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jun 2005
    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
    United States: 16
    Worldwide total number of subjects
    16
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    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
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 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
    Investigational medicinal product code
    E3810
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    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).

    Number of subjects in period 1
    		Reference/Test then Test/Reference
    Started
    16
    Completed
    15
    Not completed
    1
         Physician decision
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Reference/Test then Test/Reference
    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.

    Reporting group values
    		 Reference/Test then Test/Reference Total
    Number of subjects
    		 16 16
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 30.6 (22 to 43) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 10 10

    End points

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    End points reporting groups
    Reporting group title
    Reference/Test then Test/Reference
    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)
    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.

    Subject analysis set title
    Enteric-coated microgranule rabeprazole sodium (Test)
    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.

    Primary: Mean Area Under the Concentration Curve from Time 0 to Time t (AUC)(0-t))

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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.
    End point type
    Primary
    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.
    End point values
    		 Rabeprazole sodium (Reference) Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects analysed
    16
    15
    Units: ng*hr/mL
        geometric mean (standard deviation)
    334.5 ( 38.01 )
    321.9 ( 34.83 )
    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.
    Comparison groups
    Enteric-coated microgranule rabeprazole sodium (Test) v Rabeprazole sodium (Reference)
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 = 0.295 [2]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ratio of Test/Reference
    Point estimate
    93
    Confidence interval
         level
    		 90%
         sides
    2-sided
         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.

    Primary: Mean Log Transformed Values for AUC(0-t)

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    End point title
    		 Mean Log Transformed Values for AUC(0-t)
    End point description
    End point type
    Primary
    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
    End point values
    		 Rabeprazole sodium (Reference) Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects analysed
    16
    15
    Units: ng*hr/mL
        geometric mean (standard deviation)
    2.475 ( 0.057 )
    2.46 ( 0.059 )
    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.
    Comparison groups
    Rabeprazole sodium (Reference) v Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    P-value
    		 = 0.3325 [4]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ratio Test/Reference
    Point estimate
    92.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         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.

    Primary: Mean Area Under the Concentration Curve from Time 0 to Infinity (AUC(0 - ∞))

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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.
    End point type
    Primary
    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
    End point values
    		 Rabeprazole sodium (Reference) Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects analysed
    12 [5]
    12 [6]
    Units: ng*hr/mL
        geometric mean (standard deviation)
    378.4 ( 42.59 )
    340.8 ( 38.79 )
    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.
    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.
    Comparison groups
    Rabeprazole sodium (Reference) v Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [7]
    P-value
    		 = 0.2471 [8]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ratio of Test/Reference
    Point estimate
    91.71
    Confidence interval
         level
    		 90%
         sides
    2-sided
         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.

    Primary: Mean Maximum Drug Plasma Concentration (Cmax)

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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.
    End point type
    Primary
    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.
    End point values
    		 Rabeprazole sodium (Reference) Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects analysed
    16
    15
    Units: ng/mL
        geometric mean (standard deviation)
    256.4 ( 28.51 )
    173.6 ( 20.12 )
    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.
    Comparison groups
    Rabeprazole sodium (Reference) v Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [9]
    P-value
    		 = 0.0017 [10]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ratio of Test/Reference
    Point estimate
    65.89
    Confidence interval
         level
    		 90%
         sides
    2-sided
         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.

    Primary: Mean Log Transformed Values for Cmax

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    End point title
    		 Mean Log Transformed Values for Cmax
    End point description
    End point type
    Primary
    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
    End point values
    		 Rabeprazole sodium (Reference) Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects analysed
    16
    15
    Units: ng/mL
        geometric mean (standard deviation)
    2.36 ( 0.056 )
    2.181 ( 0.067 )
    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.
    Comparison groups
    Rabeprazole sodium (Reference) v Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [11]
    P-value
    		 = 0.0058 [12]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Ratio of Test/Reference
    Point estimate
    64.77
    Confidence interval
         level
    		 90%
         sides
    2-sided
         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.

    Primary: Mean Elimination of Half-life during the Apparent Terminal Disposition Phase (t1/2λz)

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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.
    End point type
    Primary
    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
    End point values
    		 Rabeprazole sodium (Reference) Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects analysed
    12
    12
    Units: hours
        geometric mean (standard deviation)
    0.916 ( 0.136 )
    0.937 ( 0.071 )
    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.
    Comparison groups
    Rabeprazole sodium (Reference) v Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.9797 [13]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [13] - Statistical tests were two-sided and at the significance alpha level of less than or equal to 0.05.

    Primary: Mean Time of Maximum Observed Plasma Concentration (Tmax)

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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.
    End point type
    Primary
    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.
    End point values
    		 Rabeprazole sodium (Reference) Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects analysed
    16
    15
    Units: hours
        geometric mean (standard deviation)
    3.844 ( 0.24 )
    2.367 ( 0.192 )
    Statistical analysis title
    		 Statistical Analysis of Tmax
    Comparison groups
    Enteric-coated microgranule rabeprazole sodium (Test) v Rabeprazole sodium (Reference)
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [14]
    P-value
    		 = 0 [15]
    Method
    		 t-test, 2-sided
    Confidence interval
    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.

    Secondary: Overall Acceptance of Palatability of Enteric-Coated Microgranule Rabeprazole sodium

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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.
    End point type
    Secondary
    End point timeframe
    Within 5 minutes of receiving enteric-coated microgranule formulation of rabeprazole sodium
    End point values
    		 Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects analysed
    15
    Units: Percentage of participants
    number (not applicable)
        Dislike (n = 1)
    6.7
        Like (n = 7)
    46.7
        Like very much (n = 4)
    26.7
        Neither like nor dislike (n = 2)
    13.3
        Missing (n = 1)
    6.7
    No statistical analyses for this end point

    Secondary: Palatability Taste Test Ratings of Enteric-Coated Microgranule Rabeprazole sodium

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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.
    End point type
    Secondary
    End point timeframe
    Within 5 minutes of receiving enteric-coated microgranule formulation of rabeprazole sodium
    End point values
    		 Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects analysed
    15
    Units: Percentage of participants
    number (not applicable)
        Dislike (n = 2)
    13.3
        Like (n = 7)
    46.7
        Like very much (n = 4)
    26.7
        Neither like nor dislike (n = 2)
    13.3
    No statistical analyses for this end point

    Secondary: Palatability Texture (Smoothness) Test Ratings of Enteric-Coated Microgranule Rabeprazole sodium

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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.
    End point type
    Secondary
    End point timeframe
    Within 5 minutes of receiving enteric-coated microgranule formulation of rabeprazole sodium
    End point values
    		 Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects analysed
    15
    Units: Percentage of participants
    number (not applicable)
        Dislike very much (n = 1)
    6.7
        Like (n = 5)
    33.3
        Like very much (n = 2)
    13.3
        Neither like nor dislike (n = 7)
    46.7
    No statistical analyses for this end point

    Secondary: Palatability After Taste Test Ratings of Enteric-Coated Microgranule Rabeprazole sodium

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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.
    End point type
    Secondary
    End point timeframe
    Within 5 minutes of receiving enteric-coated microgranule formulation of rabeprazole sodium
    End point values
    		 Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects analysed
    15
    Units: Percentage of participants
    number (not applicable)
        Dislike (n = 2)
    13.3
        Like (n = 4)
    26.7
        Like very much (n = 4)
    26.7
        Neither like nor dislike (n = 5)
    33.3
    No statistical analyses for this end point

    Secondary: Palatability Smell Test Ratings of Enteric-Coated Microgranule Rabeprazole sodium

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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.
    End point type
    Secondary
    End point timeframe
    Within 5 minutes of receiving enteric-coated microgranule formulation of rabeprazole sodium
    End point values
    		 Enteric-coated microgranule rabeprazole sodium (Test)
    Number of subjects analysed
    15
    Units: Percentage of participants
    number (not applicable)
        Dislike (n = 1)
    6.7
        Like (n = 6)
    40
        Like very much (n = 1)
    6.7
        Neither like nor dislike (n = 7)
    46.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    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.
    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.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7.1
    Reporting groups
    Reporting group title
    Rabeprazole sodium tablet
    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)
    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.

    Serious adverse events
    		 Rabeprazole sodium tablet Rabeprazole sodium (microgranule formula)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Rabeprazole sodium tablet Rabeprazole sodium (microgranule formula)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0

    More information

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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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