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

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

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Key information

Conditions

Bioavailability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Famotidine Tablets, 40 mg

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Perrigo Company

Industry

Registry information

Official study 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

Important dates

Study start: 2004
Primary completion: 2004
First posted: Dec 5, 2008
Registry last updated: Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed