NCT01797666

Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride Tablets Under Fasting Conditions

An Open Label, Randomized, 2-Period, 2-Treatment, 2-Sequence, Crossover, Single-Dose Bioequivalence Study of Pioglitazone Hydrochloride Tablet 45mg [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Actos® (Pioglitazone Hydrochloride) Tablet 45mg [Reference Formulation, Takeda Pharmaceuticals America, Inc.] in Healthy Human Volunteers Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Objective: subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride Tablets 1 × 45 mg and Actos® Tablets 1 × 45 mg of Takeda Pharmaceuticals America, Inc. Dosing periods of studies were separated by a washout period of 12 days and 11 days respectively. Study Design: Randomized, Two-Way Crossover, Single-Dose, and Open-Label

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Torrent's Pioglitazone Hydrochloride Tablets 45 mg

Timeline

• Primary completion: 2008-09-01
• First posted: 2013-02-22
• Last updated: 2013-02-22

Locations

1 site across 1 country: India