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

This study has been completed.

First Received: December 3, 2008 Last Updated: December 4, 2008 History of Changes

Sponsored by:	Perrigo Company
Information provided by:	Perrigo Company
ClinicalTrials.gov Identifier:	NCT00803192

Purpose

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

Condition	Intervention
Bioavailability	Drug: Famotidine Tablets, 40 mg

Drug Information available for: Famotidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
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

Further study details as provided by Perrigo Company:

Primary Outcome Measures:

Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity. [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	June 2004
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Test Drug: Active Comparator	Drug: Famotidine Tablets, 40 mg
Reference Drug: Active Comparator	Drug: Famotidine Tablets, 40 mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Perrigo ( Diane Morgan )
Study ID Numbers:	40104
Study First Received:	December 3, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00803192 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Perrigo Company:

bioavailability
famotidine

Study placed in the following topic categories:

Neurotransmitter Agents
Malnutrition
Histamine Antagonists
Famotidine

Histamine phosphate
Healthy
Histamine H2 Antagonists
Histamine

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Famotidine
Therapeutic Uses
Physiological Effects of Drugs

Anti-Ulcer Agents
Gastrointestinal Agents
Histamine Agents
Histamine H2 Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009