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
About this trial
This is an interventional treatment trial for Heartburn
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
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
NCT ID
NCT00944671
First Posted
July 22, 2009
Last Updated
June 19, 2015
Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
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)
We'll reach out to this number within 24 hrs