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目的:评价两种利福喷汀胶囊的人体生物等效性。方法:20名男性健康志愿者随机交叉单剂量口服受试制剂或参比制剂利福喷汀胶囊600 mg后,采用高效液相色谱法测定血药浓度,用DAS软件计算药动学参数,并评价其生物等效性。结果:单剂量口服利福喷汀胶囊受试制剂和参比制剂的主要药动学参数分别为:t1/2(16.44±4.99)、(18.02±4.76)h;tmax(5.6±1.4)、(6.0±1.4)h;Cmax(8.41±1.71)、(8.96±1.76)μg.ml-1;AUC(0～72)(200.41±55.29)、(220.86±62.40)μg.h.ml-1;AUC0～∞(215.58±63.51)、(241.06±75.09)μg.h.ml-1。受试制剂的相对生物利用度为(92.3±14.3)%。结论:两种制剂具有生物等效性。
Objective: To evaluate the bioequivalence of two kinds of rifapentine capsules. Methods: Twenty healthy male volunteers were randomized crossover single dose oral test formulation or reference formulation of 600 mg rifapentine capsules, the plasma concentration was determined by high performance liquid chromatography, and the pharmacokinetic parameters were calculated by DAS software. Evaluate its bioequivalence. Results: The main pharmacokinetic parameters of single-dose oral rifapentine capsules were: t1 / 2 (16.44 ± 4.99), (18.02 ± 4.76) h, tmax (5.6 ± 1.4), 6.0 ± 1.4 h; Cmax (8.41 ± 1.71), (8.96 ± 1.76) μg.ml-1; AUC (0-72) (200.41 ± 55.29), (220.86 ± 62.40) μg.h.ml- ~ ∞ (215.58 ± 63.51), (241.06 ± 75.09) μg.h.ml-1. The relative bioavailability of the test preparation was (92.3 ± 14.3)%. Conclusion: Both formulations are bioequivalent.