NCT00802828CompletedPhase 1
Randomized, 2-Way Crossover, Bioequivalence Study of Famotidine 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fasting Conditions
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Perrigo Company
- Enrollment
- 44
- Primary Endpoint
- Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity
Study Overview
Brief Summary
Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fasting conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •recipient of any drugs as part of a research study within 30 days prior to study dosing
Arms & Interventions
Test Product
Active Comparator
Intervention: Famotidine Tablets, 40 mg (Drug)
Reference Product
Active Comparator
Intervention: Famotidine Tablets, 40 mg (Drug)
Outcomes
Primary Outcomes
Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity
Secondary Outcomes
No secondary outcomes reported
Investigators
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