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PLATELET INHIBITORY ACTIVITY AND PHARAMCOKINETCS OF PRASUGREL A NOVEL THIENOPYRIDINE P2Y12 INHIBITOR: A SINGLE DOSE CROSS OVER BIOEQUIVALENCE STUDY IN HEALTHY HUMAN VOLUNTEERS

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Author(s): Sahu Nimain Charan | P. Sri Divya | S. Ramachandran | MD. Dhana Raju

Journal: International Research Journal of Pharmacy
ISSN 2230-8407

Volume: 4;
Issue: 8;
Start page: 218;
Date: 2013;
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Keywords: Prasugrel | Antiplatelet | Bioequivalence and Bioavailability | LC-MS / MS

ABSTRACT
To compare the bioavailability and bioequivalence of two prasugrel formulations one as a test and the other was the standard. The study was performed according to a randomized, open label, balanced, two-treatment, two-period, two-sequence, single-dose, crossover under fasting period with minimum of seven days wash-out period and was evaluated in 20(+ 2 stand by) subjects. To analyse pharmacokinetic properties, the blood samples were drawn taken up to 36 h after dosing. Plasma concentration of prasugrel was determined using liquid chromatography – tandem mass spectrometry method. Pharmacokinetic parameters tmax, Cmax, AUC0-t, AUC0-, t1/2 and λz (Kel) were tested for bioequivalence after log-transformation of data and non-parametric evaluation was done for ratios of tmax. The point estimates and 90 % confidence intervals (CI) for AUC0-t, AUC0-∞, and Cmax for active metabolite (R-138727) were 95.82-105.18, 96.00-104.69 and 90.80-103.20 respectively. These results indicated that the two formulations of Prasugrel were bioequivalent in case of active metabolite (R-138727), thus may be prescribed interchangeably.
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