NCT00945750

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

A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine 20 mg Film-Coated Tablets (FCT) Compared to Famotidine 20 mg Chewable Tablets (CT) Without Water and Famotidine 20 mg Chewable Tablets (CTw) With Water (Protocol 144)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heartburn

Interventions

Type	Name	Description
DRUG	Famotidine FCT	Famotidine 20 mg oral film-coated tablet taken once daily
DRUG	Famotidine CT	Famotidine 20 mg oral chewable tablet taken once daily

Timeline

• Start date: 2006-08-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2009-07-24
• Last updated: 2017-03-10
• Results posted: 2015-12-09