Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-28 @ 6:17 AM
Study NCT ID:
NCT01797666
Status:
COMPLETED
Last Update Posted:
2013-02-22
First Post:
2013-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride Tablets Under Fasting Conditions
Sponsor:
Torrent Pharmaceuticals Limited
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: