A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg FCT with water.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Famotidine

Criteria

Inclusion Criteria:

• Female participant is not pregnant or lactating

• Female of childbearing potential must use reliable means of contraception during the course of the study

• Is in good health

• Is able to abstain from smoking during the 24-hour periods before and during each treatment day

Exclusion Criteria:

• Has any major systemic disorders

• Has a history of ulcers, other Gastrointestinal (GI) disease, or GI surgery

• Has or has a history of any illness or condition that might interfere with optimal participation in the study

• Has a history of asthma or severe allergies to drugs or foods

• Currently uses prescribed or non-prescribed drugs on a regular basis

• Has a recent history of drug/alcohol abuse

• Consumes more than 6 cups of coffee per day

• Has unconventional or extreme dietary habits

• Has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days

• Has a history of allergy or intolerance to antacids

• Is known to be pregnant or is not using reliable means of contraception