Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: Bioavailability
• Interventions: Drug: Famotidine Tablets, 40 mg

• Registration Number: NCT00802828
• Lead Sponsor: Perrigo Company

Brief Summary

Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2004-06
• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• healthy men or women 18 years of age or older
• body mass index below 30.0 kg/m2
• willing to participate and sin a copy of the informed consent form

Exclusion Criteria

• recent history of drug or alcohol addiction or abuse
• pregnant or lactating women
• history of allergic response to heparin, famotidine, other H2-receptor antagonists, or other related drugs
• evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
• recipient of any drugs as part of a research study within 30 days prior to study dosing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test Product	Famotidine Tablets, 40 mg	-
Reference Product	Famotidine Tablets, 40 mg	-

Primary Outcome Measures

Name	Time	Method
Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity