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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heartburn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Famotidine/antacid combination tablet with water

Group Type ACTIVE_COMPARATOR

famotidine (+) calcium carbonate (+) magnesium hydroxide tablet

Intervention Type DRUG

A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods

B

Famotidine/Antacid EZ Chew tablet without water

Group Type EXPERIMENTAL

Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water

Intervention Type DRUG

A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods

C

Famotidine/Antacid EZ Chew tablet with water

Group Type EXPERIMENTAL

Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water

Intervention Type DRUG

A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods

Interventions

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famotidine (+) calcium carbonate (+) magnesium hydroxide tablet

A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods

Intervention Type DRUG

Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water

A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods

Intervention Type DRUG

Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water

A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes