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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648791 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg tablets to Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Finasteride Tablets 5 mg Drug: Proscar Tablets 5 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Finasteride Tablets (5 mg; Mylan) and Proscar Tablets (5 mg; Merck) in Healthy Male Volunteers |
| Enrollment: | 29 |
| Study Start Date: | September 2004 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Finasteride Tablets 5 mg
|
Drug: Finasteride Tablets 5 mg
5mg, single dose fasting
|
|
2: Active Comparator
Proscar Tablets 5 mg
|
Drug: Proscar Tablets 5 mg
5mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | FINA-0460 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00648791 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Finasteride Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions |