Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride Tablets Under Fed Conditions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01798940|
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : February 26, 2013
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.
Randomized, Two-Way Crossover, Single-Dose, and Open-Label
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Torrent's Pioglitazone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|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 Fed Conditions.|
|Actual Primary Completion Date :||September 2008|
- bioequivalence based on Composite of Pharmacokinetics [ Time Frame: Pre-dose and 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 14.0, 15.0, 16.0, 17.0, 18.0, 20.0, 24.0, 36.0, 48.0, 72.0, 96.0, 120.0 hours after dose administration. ]bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798940
|Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,|
|Village Bhat, Gandhinagar, Gujarat, India|