Bioequivalence Study of Torrent Pharmaceuticals Ltd's Clopidogrel Tablets Under Fasting Conditions
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|ClinicalTrials.gov Identifier: NCT01630642|
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : June 28, 2012
Primary objective of the present study was to compare the single dose bioavailability of Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 × 75 mg of Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA. Dosing periods were separated by a washout period of 7 days.
Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Torrent's Clopidogrel Tablets USP 75 mg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Single-Dose Bioequivalence Study of Clopidogrel Tablets USP 75mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Plavix® (Clopidogrel Bisulfate Tablets) 75mg [Reference Formulation, Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA], in Healthy Human Volunteers Under Fasting Condition.|
- bioequivalence based on Composite of Pharmacokineticsbioequivalence; 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): NCT01630642
|Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,|
|Village Bhat, Gandhinagar, Gujarat, India|