Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fasting Conditions
Study Details
Study Description
Brief Summary
Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fasting conditions.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Test Product
|
Drug: Famotidine Tablets, 40 mg
|
Active Comparator: Reference Product
|
Drug: Famotidine Tablets, 40 mg
|
Outcome Measures
Primary Outcome Measures
- Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity []
Eligibility Criteria
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
-
recipient of any drugs as part of a research study within 30 days prior to study dosing
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Perrigo Company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 40103