Clinical Trials Directory

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

TypeNameDescription
DRUGMetolazone Tablets 5 mg2x5mg, single dose fasting
DRUGZaroloxyn® Tablets 5 mg2x5mg, 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.