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Trial record 11 of 70 for:    Famotidine

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

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ClinicalTrials.gov Identifier: NCT00803192
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : March 16, 2012
Sponsor:
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
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

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Responsible Party: Perrigo Company
ClinicalTrials.gov 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:
bioavailability
famotidine
Additional relevant MeSH terms:
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Famotidine
Malnutrition
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