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目的研究国产与进口硫酸茚地那韦胶囊的生物等效性。方法20名健康男性志愿者采用随机交叉给药方案,分别单剂量口服800mg的国产硫酸茚地那韦胶囊(受试制剂)与进口硫酸茚地那韦胶囊(参比制剂),以高效液相色谱法测定茚地那韦的血药浓度。结果受试制剂与参比制剂的Cmax分别为(13·51±3·23)、(13·14±3·92)mg/L,tmax分别为(0·63±0·17)、(0·63±0·18)h,AUC0～8分别为(23·62±7·27)、(23·02±6·24)(mg·h)/L,t1/2分别为(1·2±0·5)、(1·2±0·4)h;受试制剂的相对生物利用度为(99·2±13·9)%。结论国产与进口硫酸茚地那韦胶囊的主要药动学参数均无显著性差异(P>0·05),二者具有生物等效性。
Objective To study the bioequivalence of domestic and imported indinavir sulfate capsules. Methods Twenty healthy male volunteers were randomly assigned to oral administration of 800 mg domestic indinavir sulfate capsules (test preparation) and indinavir sulfate capsules (reference formulation), respectively, in a high-performance liquid phase Determination of indinavir blood concentration by chromatography. Results The Cmax values of the tested and reference preparations were (13.51 ± 3.23) and (13.14 ± 3.92) mg / L, respectively. The tmax values were (0.63 ± 0.17) and · 63 ± 0.18) h, AUC0 ~ 8 were (23.62 ± 7.27) and (23.02 ± 6.24) mg · h-1, respectively ± 0.5, and (1.2 ± 0.4) h. The relative bioavailability of the test preparation was (99.2 ± 13.9)%. Conclusion The main pharmacokinetic parameters of domestic and imported indinavul sulfate capsules have no significant difference (P> 0.05), both of them have bioequivalence.