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CompletedNCT00802828Updated Mar 16, 2012

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

A Phase 1 interventional study of Famotidine Tablets, 40 mg in Bioavailability, sponsored by Perrigo Company. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-16.

Sponsored by Perrigo Company · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Bioavailability

Keywords

  • bioavailability
  • famotidine
03

In context

Lead sponsor

Perrigo Company is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
  • recipient of any drugs as part of a research study within 30 days prior to study dosing
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    Test Product

    Drug: Famotidine Tablets, 40 mg

  • Active comparator
    Reference Product

    Drug: Famotidine Tablets, 40 mg

Interventions

  • DrugFamotidine Tablets, 40 mg
06

What researchers measure

Primary outcomes

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00802828
Lead sponsor
Perrigo Company
Responsible party
Sponsor
First posted
Dec 5, 2008
Start date
Jun 2004
Primary completion
Jun 2004
Last update
Mar 16, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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