Bioequivalence Study of 100-mg Cilostazol Tablets in Healthy Thai Adult Volunteers

Current Therapeutic Research, Clinical and Experimental
Somruedee ChatsiricharoenkulSuvimol Niyomnaitham

Abstract

Cilostazol is a vasodilator with anticoagulant effect for treatment of peripheral vascular disease. Cilostazol 100-mg tablet was shown to increase walking distance in this patient population. The aim of this study was to investigate and compare the pharmacokinetic profiles and safety of Bestazol 100-mg tablet (Berlin Pharmaceutical Industry Co Ltd, Bangkok, Thailand), which is a generic formulation of cilostazol, with the original brand Pletaal 100-mg tablet (Korea Otsuka Pharmaceutical Co Ltd, Seoul, South Korea) in healthy Thai adult volunteers. The pharmacokinetic profiles of Bestazol (test) and Pletaal (reference) 100-mg tablets were compared in a single-dose, open-label, 2-treatment, 2-period, 2-sequence, randomized crossover study in healthy Thai adult volunteers. This study was conducted at the Siriraj Clinical Research Center, Siriraj Hospital, Mahidol University, Bangkok, Thailand. Each volunteer was initially treated according to either the test-reference or the reference-test sequence, after which each volunteer was switched to the other study sequence after a 2-week washout period. Pharmacokinetic analysis was performed using log-transformed ratios for Cmax, AUC0-last, AUC0-∞, Tmax, t1/2, and λZ for both cilostazol ...Continue Reading

Methods Mentioned

BETA
pregnancy test

Software Mentioned

WinNonlin
Kinetics
Bestazol
Pletaal

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