Bioequivalence study of two formulations of simvastatin tablets in healthy Thai volunteers.
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.
Bioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand, manupatl@hotmail.com
Manupat
M
Lohitnavy
Ornrat
O
Lohitnavy
Kasinee
K
Chaijittiprasert
Prawit
P
Taytiwat
Sanglar
S
Polnok
D000293:Adolescent; D000328:Adult; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D006207:Half-Life; D006801:Humans; D008297:Male; D008875:Middle Aged; D019821:Simvastatin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D021241:Spectrometry, Mass, Electrospray Ionization; D013607:Tablets; D013785:Thailand; D013810:Therapeutic Equivalency
D000924:Anticholesteremic Agents; D013607:Tablets; D019821:Simvastatin