Bioequivalence study of two formulations of simvastatin tablets in healthy Thai volunteers.

Manupat Lohitnavy, Ornrat Lohitnavy, Kasinee Chaijittiprasert, Prawit Taytiwat, Sanglar Polnok

Bioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand, manupatl@hotmail.com

Arzneimittel-Forschung 2004

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The bioequivalence of two formulations of 10 mg tablets of simvastatin (CAS 79902-63-9), Vascor as test and a commercially available preparation as reference, in 18 healthy Thai male volunteers was assessed. In a randomized, single dose, two-period, crossover study design with a 1-week wash-out period, each subject received 4 tablets of 10-mg simvastatin tablets. Plasma samples were collected over a 24-h period after administration. Subsequently, plasma concentrations of simvastatin and its hydroxy acid metabolite were analyzed by using LC/ MS/MS. Pharmacokinetic parameters were determined by using non-compartmental analysis. The results showed that 90% confidence intervals of the peak concentration (Cmax) and the area under the concentration-time curve (AUC) of simvastatin and its hydroxy acid metabolite of reference and test were within 80 %-125%. Consequently the bioequivalence of these two preparations can be concluded.

Citation

Manupat Lohitnavy, Ornrat Lohitnavy, Kasinee Chaijittiprasert, Prawit Taytiwat, Sanglar Polnok. Bioequivalence study of two formulations of simvastatin tablets in healthy Thai volunteers. Arzneimittel-Forschung. 2004;54(1):31-4