Bioequivalence Evaluation of Two Brands of Zolpidem Tartrate 10 mg Tablets(Zanilo and Stilnox) in Healthy Male Volunteers

摘要: The purpose of the present study was to evaluate bioequivalence two zolpidem tartrate tablets, Stilnox tablet(Sanofi-aventis Korea, reference product) and Zanilo tablet(ChoDang Pharm Co., Ltd., test product), according guidelines Korea Food Drug Administration(KFDA). After adding an internal standard(cimetropium), 250 plasma samples were extracted using 1.3 mL ethyl acetate. Extracted compounds analyzed by HPLC with triple-quadrupole mass spectrometry. This method for determination is proved accurate reproducible limit quantitation 1 ng/mL in human plasma. Twenty-four healthy male Korean volunteers received each medicine at dose 10 mg a crossover study. There one-week washout period between doses. Plasma concentrations monitored over 8 hr after administration. (the area under concentration-time curve) calculated linear trapezoidal rule. (maximum drug concentration) (time reach ) compiled from data. Analysis variance carried out logarithmically transformed . No significant sequence effect found all bio-availability parameters indicating that design properly performed. 90% confidence intervals log data acceptable range 0.8 1.25(e.g., 0.92-log 1.06 , 0.96-log 1.13 ). major parameters, met criteria KFDA tablet bioequivalent tablet.