Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets Under Fasting Conditions
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|ClinicalTrials.gov Identifier: NCT01634386|
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : July 6, 2012
Primary objective of the present study was to compare the single dose bioequivalence of Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the fed were separated by a washout period of 7 days.
Open label, Randomized, Two-Way, Crossover, Single-Dose Bioequivalence Study
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Torrent's Quetiapine Fumarate Tablets||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||An Open-Label, Randomised, 2-Period, 2-Treatment, 2-sequence, Crossover, Single-dose Bioequivalence Study of Quetiapine 25 mg Tablet [Test Formulation; Torrent Pharmaceuticals Ltd., India] Versus Seroquel® 25 mg Tablet [Reference Formulation; AstraZeneca, USA] in Healthy Human Volunteers Under Fasting Condition.|
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): NCT01634386
|Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,|
|Village Bhat, Gandhinagar, Gujarat, India|