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Trial record 11 of 70 for:    Famotidine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00803192
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : March 16, 2012
Information provided by (Responsible Party):
Perrigo Company

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

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Study Type : Interventional  (Clinical Trial)
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 : June 2004
Actual Primary Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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

Primary Outcome Measures :
  1. Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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Responsible Party: Perrigo Company Identifier: NCT00803192     History of Changes
Other Study ID Numbers: 40104
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012
Keywords provided by Perrigo Company:
Additional relevant MeSH terms:
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Nutrition Disorders
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs