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目的:以进口恩曲他滨胶囊为参比制剂,评价国产恩曲他滨胶囊的人体生物等效性。方法:18名健康男性受试者按两制剂两周期的交叉试验设计口服单剂量200 mg的参比制剂和受试制剂后,采用高效液相色谱法测定血浆中恩曲他滨的浓度,使用DAS 1.0软件计算药物动力学参数并进行生物等效性统计分析。结果:参比制剂和受试制剂的C_(max)分别为(2.42±0.51)μg·ml~(-1)和(2.34±0.52)μg·ml~(-1);t_(max)分别为(1.19±0.31)h和(1.17±0.37)h;AUC_(0-16h)分别为(9.40±1.88)μg·ml~(-1)·h和(9.58±1.84)μg·ml~(-1)·h;AUC_(0-∞)分别为(9.68±1.88)μg·ml~(-1)·h和(9.87±1.86)μg·ml~(-1)·h。受试制剂的相对生物利用度为(102.6±10.8)%。结论:两种制剂具有生物等效性。
OBJECTIVE: To evaluate the human bioequivalence of domestically produced Emtricitabine capsules with imported Emtricitabine as reference preparation. Methods: Eighteen healthy male subjects were given a single oral dose of 200 mg of the reference formulation and the test formulation by two-period crossover test. The concentration of emtricitabine in plasma was determined by HPLC. The DAS 1.0 software calculates pharmacokinetic parameters and performs bioequivalence statistical analysis. Results: The C max of the reference preparation and the test preparation were (2.42 ± 0.51) μg · ml -1 and (2.34 ± 0.52) μg · ml -1, respectively; the t max were (1.19 ± 0.31) h and (1.17 ± 0.37) h respectively; AUC0-16h were (9.40 ± 1.88) μg · ml -1 · h and (9.58 ± 1.84) μg · ml -1 ) · H and AUC_ (0-∞) were (9.68 ± 1.88) μg · ml -1 · h and (9.87 ± 1.86) μg · ml -1 · h, respectively. The relative bioavailability of the test preparation was (102.6 ± 10.8)%. Conclusion: Both formulations are bioequivalent.