Bioequivalence Study of Torrent Pharmaceuticals Ltd's Clopidogrel Tablets Under Fasting Conditions
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
|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.|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630642
|Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,|
|Village Bhat, Gandhinagar, Gujarat, India|