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Single-Dose Fasting In Vivo Bioequivalence Study of Metolazone Tablets (2.5 mg; Mylan) and Zaroloxyn® Tablets (2.5 mg; Celltech) in Healthy Volunteers
The objective of this study was to investigate the bioequivalence of Mylan metolazone 2.5 mg tablets to Celltech Zaroxolyn® 2.5 mg tablets following a single, oral 10 mg (4 x 2.5 mg) dose administration under fasting conditions.
Details
| Lead sponsor | Mylan Pharmaceuticals Inc |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 52 |
| Start date | 2002-12 |
| Completion | 2003-01 |
Conditions
- Healthy
Interventions
- Metolazone Tablets 2.5 mg
- Zaroloxyn® Tablets 2.5 mg
Primary outcomes
- Bioequivalence — within 30 days
Countries
United States