Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fed Conditions
Randomized, 2-Way Crossover, Bioequivalence Study of Famotidine 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fed Conditions
1 other identifier
interventional
44
0 countries
N/A
Brief Summary
Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fed conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 3, 2008
CompletedFirst Posted
Study publicly available on registry
December 5, 2008
CompletedMarch 16, 2012
March 1, 2012
Same day
December 3, 2008
March 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity.
Study Arms (2)
Test Drug
ACTIVE COMPARATORReference Drug
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Perrigo Companylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2008
First Posted
December 5, 2008
Study Start
June 1, 2004
Primary Completion
June 1, 2004
Last Updated
March 16, 2012
Record last verified: 2012-03