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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Treatments: Antacids; Anti-Ulcer Agents; Calcium; Calcium Carbonate; Calcium, Dietary; Famotidine; Magnesium Hydroxide

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