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Fasting Study of Metolazone Tablets 5 mg and Zaroloxyn® Tablets 5 mg

NCT00649181 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-04-24

No results posted yet for this study

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

  • Healthy

Interventions

DRUG

Metolazone Tablets 5 mg

2x5mg, single dose fasting

DRUG

Zaroloxyn® Tablets 5 mg

2x5mg, single dose fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Thomas S Clark, M.D. · Kendle International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2003-11-30
Completion
2003-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00649181 on ClinicalTrials.gov