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NCT00649558 · ClinicalTrials.gov registry record · Phase 1

Fasting Study of Pioglitazone HCl Tablets 45 mg and Actos® Tablets 45 mg

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT00649558: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.

NCT00649558 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00649558, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study Summary

The objective of this study was to investigate the bioequivalence of Mylan pioglitazone HCl 45 mg tablets to Takeda Actos® 45 mg tablets following a single, oral 45 mg (1 x 45 mg) dose administration under fasting conditions.

Interventions

  • DRUG Pioglitazone HCl Tablets 45 mg
  • DRUG Actos® Tablets 45 mg

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2003-02
Est. Completion 2003-03
Phase Phase 1
Mylan Pharmaceuticals

146 total trials

What the finished NCT00649558 record still lists

NCT00649558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 2 interventions - of which Pioglitazone HCl Tablets 45 mg is the first listed.

NCT00649558 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00649558 about?

NCT00649558 is a clinical study titled "Fasting Study of Pioglitazone HCl Tablets 45 mg and Actos® Tablets 45 mg". The objective of this study was to investigate the bioequivalence of Mylan pioglitazone HCl 45 mg tablets to Takeda Actos® 45 mg tablets following a single, oral 45 mg (1 x 45 mg) dose administration under fasting conditions.

What is the current status of trial NCT00649558?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2003-02. Estimated completion is 2003-03.

What interventions are being tested in trial NCT00649558?

The interventions under investigation include: Pioglitazone HCl Tablets 45 mg (DRUG), Actos® Tablets 45 mg (DRUG).

Who is sponsoring clinical trial NCT00649558?

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 NCT00649558's enrollment target sits among peer trials

36 1210th of 2000 higher than 743 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 NCT00649558, the US trial registry maintained by the National Library of Medicine. NCT00649558 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.