Trials / Completed
CompletedNCT00649181
Fasting Study of Metolazone Tablets 5 mg and Zaroloxyn® Tablets 5 mg
Single-Dose Fasting In Vivo Bioequivalence Study of Metolazone Tablets (5 mg; Mylan) and Zaroloxyn® Tablets (5 mg; Celltech) in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Mylan Pharmaceuticals Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study was to investigate the bioequivalence of Mylan metolazone 5 mg tablets to Celltech Zaroxolyn® 5 mg tablets following a single, oral 10 mg (2 x 5 mg) dose administration under fasting conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Metolazone Tablets 5 mg | 2x5mg, single dose fasting |
| DRUG | Zaroloxyn® Tablets 5 mg | 2x5mg, single dose fasting |
Timeline
- Start date
- 2003-10-01
- Primary completion
- 2003-11-01
- Completion
- 2003-11-01
- First posted
- 2008-04-01
- Last updated
- 2024-04-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00649181. Inclusion in this directory is not an endorsement.