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目的研究中国健康受试者单次口服左炔诺孕酮片的生物等效性。方法将20名健康女性受试者随机分为2组,分别单剂量口服给予受试制剂或参比制剂各1.5 mg,洗脱1周后,交叉给药,用LC-MS/MS法测定血药浓度,计算两者的主要药动学参数和相对生物利用度。结果口服受试制剂或参比制剂后,血浆中左炔诺孕酮的主要药动学参数:T_(max)分别为1.79±0.17、1.83±0.16 h,C_(max)分别为20.93±2.89、19.74±3.13 ng·m L~(-1),以AUC_(0→∞)计,受试制剂的相对生物利用度为102.2%±30.1%。结论受试制剂与参比制剂在健康受试者体内具有生物等效性。
Objective To study the bioequivalence of single oral levonorgestrel tablets in Chinese healthy subjects. Methods Twenty healthy female subjects were randomly divided into two groups, each of which was orally administered with 1.5 mg of each test preparation or reference preparation. After one week of elution, the drug was administered orally and the blood was determined by LC-MS / MS Drug concentration, calculate the two main pharmacokinetic parameters and relative bioavailability. Results The main pharmacokinetic parameters of levonorgestrel in plasma were 1.79 ± 0.17, 1.83 ± 0.16 h and C max of 20.93 ± 2.89, respectively, after oral administration of the test preparation or reference preparation. 19.74 ± 3.13 ng · m L -1. The relative bioavailability of the test preparation was 102.2% ± 30.1% based on AUC_ (0 → ∞). Conclusion The test and reference preparations are bioequivalent in healthy subjects.