复方左炔诺孕酮片在健康人体的生物等效性研究

Bioequivalence of compound levonorgestrel tablets in healthy volunteers

目的:评价两种复方左炔诺孕酮片在健康人体内的生物等效性。方法:19名健康男性受试者随机交叉给药,分别单次口服复方左炔诺孕酮片受试制剂或参比制剂1片(每片含左炔诺孕酮0.15mg和炔雌醇0.03mg),用放射免疫测定法测定左炔诺孕酮和炔雌醇的血药浓度,计算两种制剂中左炔诺孕酮和炔雌醇的药动学参数,并评价其生物等效性。结果:除了左炔诺孕酮的t1/2以外,受试制剂与参比制剂中左炔诺孕酮和炔雌醇的主要药动学参数无统计学差异(P>0.05)。受试制剂中左炔诺孕酮的相对生物利用度为(101.59±20.30)%,炔雌醇的相对生物利用度为(113.57±26.70)%。结论:两种复方左炔诺孕酮片具有生物等效性。

Objective：To study the bioequivalence of two compound levonorgestrel tablets in healthy volunteers.Methods：A single dose of compound levonorgestrel test and reference tablets were orally administered to nineteen male healthy volunteers in a randomized crossover study.Concentrations of levonorgestrel and ethinyloestradiol were determined by radioimmunoassay.The pharmacokinetic parameters of levonorgestrel and ethinyloestradiol were calculated and bioequivalence of the two preparations were evaluated.Results：There were no significant differences in pharmacokinetic parameters of the two preparations（P0.05）,except t1/2 of levonorgestrel.Relative bioavailability of levonorgestrel in the test preparation was（101.59±20.30）% and that of ethinyloestradiol was（113.57±26.70）%.Conclusion：The two preparations of compound levonorgestrel tablets are bioequivalent.