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Single-Dose Fasting In Vivo Bioequivalence Study of Mercaptopurine (50 mg; Mylan) and Purinethol® Tablets (50 mg; Gate) in Healthy Male Volunteers
The objective of this study was to investigate the bioequivalence of Mylan's mercaptopurine 50 mg tablets to Gate's Purinethol® 50 mg tablets following a single, oral 50 mg (1 x 50 mg) dose administered under fasting conditions.
Details
| Lead sponsor | Mylan Pharmaceuticals Inc |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 60 |
| Start date | 2003-11 |
| Completion | 2003-12 |
Conditions
- Healthy
Interventions
- Mercaptopurine 50 mg
- Purinethol® Tablets 50 mg
Primary outcomes
- Bioequivalence — within 30 days
Countries
United States