Single-Dose Fasting In Vivo Bioequivalence Study of Metolazone Tablets (5 mg; Mylan) and Zaroloxyn® Tablets (5 mg; Celltech) in Healthy Volunteers

NCT00649181 Phase 1 COMPLETED

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.

Details

Lead sponsor	Mylan Pharmaceuticals Inc
Phase	Phase 1
Status	COMPLETED
Enrolment	52
Start date	2003-10
Completion	2003-11

Conditions

• Healthy

Interventions

• Metolazone Tablets 5 mg
• Zaroloxyn® Tablets 5 mg

Primary outcomes

• Bioequivalence — within 30 days

Countries

United States