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

• Sponsor: Perrigo Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00803192
• Collaborator: (none)
• Enrollment: 44
• Arms: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bioavailability	Drug: Famotidine Tablets, 40 mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized, 2-Way Crossover, Bioequivalence Study of Famotidine 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fed Conditions
• Study Start Date: Jun 1, 2004
• Actual Primary Completion Date: Jun 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Test Drug	Drug: Famotidine Tablets, 40 mg
Active Comparator: Reference Drug	Drug: Famotidine Tablets, 40 mg

Outcome Measures

Primary Outcome Measures

1. Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

• smoking more than 25 cigarettes per day

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Perrigo Company

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Perrigo Company
• ClinicalTrials.gov Identifier: NCT00803192
• Other Study ID Numbers: 40104
• First Posted: Dec 5, 2008
• Last Update Posted: Mar 16, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Perrigo Company: bioavailability; famotidine
• Additional relevant MeSH terms: Malnutrition; Famotidine

Study Results

No Results Posted as of Mar 16, 2012