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NCT00650195 · ClinicalTrials.gov registry record · Phase 1

Fasting Study of Metolazone Tablets 10 mg and Zaroloxyn® Tablets 10 mg

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
56
Enrollment target

NCT00650195: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.

NCT00650195 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00650195, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
56 participants
Enrollment target

Study Summary

The objective of this study was to investigate the bioequivalence of Mylan metolazone 10 mg tablets to Celltech Zaroxolyn® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose administration under fasting conditions.

Interventions

  • DRUG Metolazone Tablets 10 mg
  • DRUG Zaroloxyn® Tablets 10 mg

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2004-02
Est. Completion 2004-03
Phase Phase 1
Mylan Pharmaceuticals

146 total trials

What the finished NCT00650195 record still lists

NCT00650195 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Metolazone Tablets 10 mg is the first listed.

NCT00650195 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00650195 about?

NCT00650195 is a clinical study titled "Fasting Study of Metolazone Tablets 10 mg and Zaroloxyn® Tablets 10 mg". The objective of this study was to investigate the bioequivalence of Mylan metolazone 10 mg tablets to Celltech Zaroxolyn® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose administration under fasting conditions.

What is the current status of trial NCT00650195?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2004-02. Estimated completion is 2004-03.

What interventions are being tested in trial NCT00650195?

The interventions under investigation include: Metolazone Tablets 10 mg (DRUG), Zaroloxyn® Tablets 10 mg (DRUG).

Who is sponsoring clinical trial NCT00650195?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00650195's enrollment target sits among peer trials

56 902nd of 2000 higher than 1,083 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00650195, the US trial registry maintained by the National Library of Medicine. NCT00650195 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.