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

Phase 1

Completed

• Conditions: Heartburn
• Interventions: Drug: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet

• Registration Number: NCT00944671
• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Results First Submitted: 2014-10-27
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-19
• Last Update Submitted: 2015-06-19
• Results First Posted: 2015-06-24
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	famotidine (+) calcium carbonate (+) magnesium hydroxide tablet	Famotidine/antacid combination tablet with water

Primary Outcome Measures

Name	Time	Method
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	Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water	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 Measures

Name	Time	Method
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	Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water	Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)