Status:

COMPLETED

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

Lead Sponsor:

Perrigo Company

Conditions:

Bioavailability

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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
  • recipient of any drugs as part of a research study within 30 days prior to study dosing

Key Trial Info

Start Date :

June 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

44 Patients enrolled

Trial Details

Trial ID

NCT00802828

Start Date

June 1 2004

Last Update

March 16 2012

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