NCT00649051

Fasting Study of Metolazone Tablets 2.5 mg and Zaroloxyn® Tablets 2.5 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Metolazone Tablets (2.5 mg; Mylan) and Zaroloxyn® Tablets (2.5 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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Metolazone Tablets 2.5 mg	4x2.5mg, single dose fasting
DRUG	Zaroloxyn® Tablets 2.5 mg	4x2.5mg, single dose fasting

Timeline

• Start date: 2002-12-01
• Primary completion: 2002-12-01
• Completion: 2003-01-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States