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20名女性健康志愿者随机分成两组,采用自身对照交叉给药的方式,单剂量口服两种左炔诺孕酮片,采用放射免疫分析法测定血药浓度。20名志愿者口服左炔诺孕酮受试和参比制剂后的药动学参数分别为:tmax(1.9±0.2)和(2.0±0.1)h,cmax(6.34±1.16)和(6.86±1.07)ng/ml,MRT(30.48±4.85)和(29.26±4.71)h,t1/2(24.60±4.28)和(24.12±4.61)h,AUC0→72 h(92.43±24.24)和(101.09±31.21)h.ng.ml-1,AUC0→∞(104.41±29.25)和(113.06±36.07)h.ng.ml-1。受试制剂的相对生物利用度为(93.5±16.2)%。
Twenty female healthy volunteers were randomly divided into two groups. Two levonorgestrel tablets were orally administered in a self-controlled crossover manner. Radioimmunoassay was used to determine plasma concentration. The pharmacokinetic parameters of 20 volunteers after levonorgestrel test and reference preparation were: tmax (1.9 ± 0.2) and (2.0 ± 0.1) h, cmax (6.34 ± 1.16) and (6.86 ± 1.07 (30.48 ± 4.85) and (29.26 ± 4.71) h, t1 / 2 (24.60 ± 4.28) and (24.12 ± 4.61) h, AUC0 → 72 h (92.43 ± 24.24) and (101.09 ± 31.21) h.ng.ml-1, AUC0 → ∞ (104.41 ± 29.25) and (113.06 ± 36.07) h.ng.ml-1. The relative bioavailability of the test preparation was (93.5 ± 16.2)%.