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A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)

Primary Purpose

Heartburn

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Famotidine FCT
Famotidine CT
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heartburn

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Female participant is not pregnant or lactating
  • Female of childbearing potential must use reliable means of contraception during the course of the study
  • Is in good health
  • Is able to abstain from smoking during the 24-hour periods before and during each treatment day

Exclusion Criteria:

  • Has any major systemic disorders
  • Has a history of ulcers, other Gastrointestinal (GI) disease, or GI surgery
  • Has or has a history of any illness or condition that might interfere with optimal participation in the study
  • Has a history of asthma or severe allergies to drugs or foods
  • Currently uses prescribed or non-prescribed drugs on a regular basis
  • Has a recent history of drug/alcohol abuse
  • Consumes more than 6 cups of coffee per day
  • Has unconventional or extreme dietary habits
  • Has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days
  • Has a history of allergy or intolerance to antacids
  • Is known to be pregnant or is not using reliable means of contraception

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Sequence 1: FCT with water → CT without water → CT with water

    Sequence 2: CT without water → CT with water → FCT with water

    Sequence 3: CT with water → FCT with water → CT without water

    Sequence 4: FCT with water → CT with water → CT without water

    Sequence 5: CT without water → FCT with water → CT with water

    Sequence 6: CT with water → CT without water → FCT with water

    Arm Description

    Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3).

    Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).

    Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3).

    Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3).

    Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3).

    Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).

    Outcomes

    Primary Outcome Measures

    Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-∞) Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water
    AUC values were natural log-transformed and analyzed using an analysis of variance (ANOVA) model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
    Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water
    Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.

    Secondary Outcome Measures

    AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
    AUC values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
    Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
    Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.

    Full Information

    First Posted
    July 22, 2009
    Last Updated
    January 30, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00945750
    Brief Title
    A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)
    Official Title
    A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine 20 mg Film-Coated Tablets (FCT) Compared to Famotidine 20 mg Chewable Tablets (CT) Without Water and Famotidine 20 mg Chewable Tablets (CTw) With Water (Protocol 144)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    September 2006 (Actual)
    Study Completion Date
    September 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg FCT with water.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heartburn

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sequence 1: FCT with water → CT without water → CT with water
    Arm Type
    Experimental
    Arm Description
    Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3).
    Arm Title
    Sequence 2: CT without water → CT with water → FCT with water
    Arm Type
    Experimental
    Arm Description
    Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).
    Arm Title
    Sequence 3: CT with water → FCT with water → CT without water
    Arm Type
    Experimental
    Arm Description
    Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3).
    Arm Title
    Sequence 4: FCT with water → CT with water → CT without water
    Arm Type
    Experimental
    Arm Description
    Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3).
    Arm Title
    Sequence 5: CT without water → FCT with water → CT with water
    Arm Type
    Experimental
    Arm Description
    Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3).
    Arm Title
    Sequence 6: CT with water → CT without water → FCT with water
    Arm Type
    Experimental
    Arm Description
    Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).
    Intervention Type
    Drug
    Intervention Name(s)
    Famotidine FCT
    Intervention Description
    Famotidine 20 mg oral film-coated tablet taken once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Famotidine CT
    Intervention Description
    Famotidine 20 mg oral chewable tablet taken once daily
    Primary Outcome Measure Information:
    Title
    Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-∞) Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water
    Description
    AUC values were natural log-transformed and analyzed using an analysis of variance (ANOVA) model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
    Time Frame
    0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
    Title
    Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water
    Description
    Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
    Time Frame
    0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
    Secondary Outcome Measure Information:
    Title
    AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
    Description
    AUC values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
    Time Frame
    0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
    Title
    Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
    Description
    Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
    Time Frame
    0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female participant is not pregnant or lactating Female of childbearing potential must use reliable means of contraception during the course of the study Is in good health Is able to abstain from smoking during the 24-hour periods before and during each treatment day Exclusion Criteria: Has any major systemic disorders Has a history of ulcers, other Gastrointestinal (GI) disease, or GI surgery Has or has a history of any illness or condition that might interfere with optimal participation in the study Has a history of asthma or severe allergies to drugs or foods Currently uses prescribed or non-prescribed drugs on a regular basis Has a recent history of drug/alcohol abuse Consumes more than 6 cups of coffee per day Has unconventional or extreme dietary habits Has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days Has a history of allergy or intolerance to antacids Is known to be pregnant or is not using reliable means of contraception
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=0208-144&kw=0208-144&tab=access

    Learn more about this trial

    A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)

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