NCT00649012

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

Single-Dose Food In Vivo Bioequivalence Study of Pioglitazone HCl Tablets (45 mg; Mylan) to Actos® Tablets (45 mg; Takeda) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (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 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

Type	Name	Description
DRUG	Pioglitazone HCl Tablets 45 mg	45mg, single dose fed
DRUG	Actos® Tablets 45 mg	45mg, single dose fed

Timeline

• Start date: 2003-03-01
• Primary completion: 2003-03-01
• Completion: 2003-03-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States