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Food Study of Pioglitazone HCl Tablets 45 mg to Actos® Tablets 45 mg

NCT00649012 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

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 pioglitazone HCl 45 mg tablets to Takeda Actos® 45 mg tablets following a single, oral 45 mg (1 x 45 mg) dose administration under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Pioglitazone HCl Tablets 45 mg

45mg, single dose fed

DRUG

Actos® Tablets 45 mg

45mg, single dose fed

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • James D Carlson, Pharm. D. · PRACS Institute Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2003-03-31
Completion
2003-03-31

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 NCT00649012 on ClinicalTrials.gov