Lohitnavy Manupat, Chaijittiprasert Kasinee, Polnok Sanglar, Lohitnavy Ornrat, Taytiwat Prawit
Bioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.
J Med Assoc Thai. 2002 Jul;85(7):808-13.
To assess the average bioequivalence of two formulations of 8-mg ondansetron tablets--test product (Unison Laboratories, Thailand) and reference product (Glaxo Wellcome, USA)--in 14 healthy Thai male volunteers.
In a randomized, single dose, fasting, two-period, crossover study design with a 1-week washout period, each subject received an 8-mg ondansetron tablet. Serum samples were collected over a 24-hour period after administration. Subsequently serum concentrations of ondansetron were analyzed by using a validated HPLC-UV method. Pharmacokinetic parameters were determined by using non-compartmental analysis.
No significant difference was observed in any of the pharmacokinetic parameters analyzed. The time to reach the maximal concentration (Tmax, hour), the peak concentration (Cmax, ng/ ml) and the area under the concentration-time curve (AUC(0-infinity), ng x h/ml) of ondansetron for reference and test preparations were 2.6 + 1.8 vs 2.2 + 0.6, 49.5 +/- 18.9 vs 48.5 +/- 13.7 and 352.2 +/- 184.7 vs 323.8 +/- 154.5, respectively. The 90 per cent confidence intervals for Test/Reference ratio of Cmax and AUC(0-infinity) were found within the bioequivalence range of 80-125 per cent (90.3-110.0% and 88.4-99.6%, respectively).
The bioequivalence of these two ondansetron preparations was demonstrated.
评估两种8毫克昂丹司琼片剂（试验产品，泰国Unison实验室；参比产品，美国葛兰素威康）在14名健康泰国男性志愿者中的平均生物等效性。
采用随机、单剂量、空腹、两周期交叉研究设计，洗脱期为1周，每位受试者服用1片8毫克昂丹司琼片剂。给药后24小时内采集血清样本。随后采用经过验证的高效液相色谱-紫外检测法分析血清中昂丹司琼的浓度。采用非房室分析方法确定药代动力学参数。
在所分析的任何药代动力学参数中均未观察到显著差异。参比制剂和试验制剂的昂丹司琼达峰时间（Tmax，小时）、峰浓度（Cmax，纳克/毫升）和浓度-时间曲线下面积（AUC(0-∞)，纳克·小时/毫升）分别为2.6±1.8对2.2±0.6、49.5±18.9对48.5±13.7、352.2±184.7对323.8±154.5。Cmax和AUC(0-∞)的试验/参比比值的90%置信区间在生物等效性范围80%-125%内（分别为90.3%-110.0%和88.4%-99.6%）。
证明了这两种昂丹司琼制剂具有生物等效性。
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