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A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)

Primary Purpose

Heartburn

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
famotidine (+) calcium carbonate (+) magnesium hydroxide tablet
Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water
Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water
Sponsored by
Johnson & Johnson Consumer and Personal Products Worldwide
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 subject is not pregnant or lactating, Females of childbearing potential must use reliable means of contraception during the course of the study
  • Subject is in good health
  • Subject is able to abstain from smoking during the 24-hour periods before and during each treatment day

Exclusion Criteria:

  • Subject has a history of stomach ulcers, other Gastrointestinal (GI) diseases or GI surgery
  • Subject has a history of asthma or severe allergies to drugs or foods
  • Subject currently uses prescribed or nonprescribed drugs on a regular basis
  • Subject has a recent history of drug/alcohol abuse
  • Subject consumes more than 6 cups of coffee per day
  • Subject has unconventional or extreme dietary habits
  • Subject has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days
  • Subject has a history of allergy or intolerance to antacids
  • Female subject 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 Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    A

    B

    C

    Arm Description

    Famotidine/antacid combination tablet with water

    Famotidine/Antacid EZ Chew tablet without water

    Famotidine/Antacid EZ Chew tablet with water

    Outcomes

    Primary Outcome Measures

    Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
    Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water

    Secondary Outcome Measures

    Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water
    Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water

    Full Information

    First Posted
    July 22, 2009
    Last Updated
    June 19, 2015
    Sponsor
    Johnson & Johnson Consumer and Personal Products Worldwide
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00944671
    Brief Title
    A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)
    Official Title
    A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets (FACT) Compared to Famotidine/Antacid EZ Chew Tablet Without Water and Famotidine/Antacid EZ Chew Tablet With Water
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2008 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johnson & Johnson Consumer and Personal Products Worldwide

    4. Oversight

    5. Study Description

    Brief Summary
    A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew tablet taken without water and with water compared to the Famotidine/Antacid tablet taken with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days.

    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
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Active Comparator
    Arm Description
    Famotidine/antacid combination tablet with water
    Arm Title
    B
    Arm Type
    Experimental
    Arm Description
    Famotidine/Antacid EZ Chew tablet without water
    Arm Title
    C
    Arm Type
    Experimental
    Arm Description
    Famotidine/Antacid EZ Chew tablet with water
    Intervention Type
    Drug
    Intervention Name(s)
    famotidine (+) calcium carbonate (+) magnesium hydroxide tablet
    Intervention Description
    A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water
    Intervention Description
    A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water
    Intervention Description
    A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods
    Primary Outcome Measure Information:
    Title
    Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
    Time Frame
    Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
    Title
    Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
    Time Frame
    Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
    Secondary Outcome Measure Information:
    Title
    Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water
    Time Frame
    Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
    Title
    Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water
    Time Frame
    Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 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 subject is not pregnant or lactating, Females of childbearing potential must use reliable means of contraception during the course of the study Subject is in good health Subject is able to abstain from smoking during the 24-hour periods before and during each treatment day Exclusion Criteria: Subject has a history of stomach ulcers, other Gastrointestinal (GI) diseases or GI surgery Subject has a history of asthma or severe allergies to drugs or foods Subject currently uses prescribed or nonprescribed drugs on a regular basis Subject has a recent history of drug/alcohol abuse Subject consumes more than 6 cups of coffee per day Subject has unconventional or extreme dietary habits Subject has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days Subject has a history of allergy or intolerance to antacids Female subject is known to be pregnant or is not using reliable means of contraception
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)

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