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目的:评价左炔诺孕酮片在健康人体内的药动学与生物等效性。方法:20名健康中国女性志愿者随机交叉单剂量口服左炔诺孕酮片后,取血,采用LC-MS/MS法测定血浆中药物浓度。结果:单次口服左炔诺孕酮片参比制剂和试验制剂1.5 mg后的Cmax分别为(24.58±10.48)和(24.09±10.15)ng.mL-1;Tmax分别为(1.8±0.2)和(1.7±0.2)h;AUC0~72 h分别为(241.9±99.8)和(244.9±105.8)ng.h.mL-1。试验制剂相对于参比制剂的生物利用度F分别为(102.6±24.8)%。结论:试验制剂左炔诺孕酮分散片与参比制剂左炔诺孕酮片具有生物等效性。
Objective: To evaluate the pharmacokinetics and bioequivalence of levonorgestrel tablets in healthy volunteers. Methods: Twenty healthy female volunteers in China were randomized to receive a single oral dose of levonorgestrel and blood samples were collected for determination of plasma drug concentration by LC-MS / MS. Results: The Cmax values of single-dose levonorgestrel tablets and test preparations after 1.5 mg were (24.58 ± 10.48) and (24.09 ± 10.15) ng.mL-1, respectively; the Tmax were (1.8 ± 0.2) and (1.7 ± 0.2) h; AUC0 ~ 72 h were (241.9 ± 99.8) and (244.9 ± 105.8) ng.h.mL-1, respectively. The bioavailability F of the test formulation relative to the reference formulation was (102.6 ± 24.8)%, respectively. Conclusion: The levonorgestrel dispersible tablets were bioequivalent to levonorgestrel tablets.