国产硫酸茚地那韦胶囊人体药动学及生物等效性研究

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。

Study on the Pharmacokinetics and Bioequivalance of Domestic Indinavir Sulfate in Healthy Chinese Volunteers

OBJECTIVE:To study the pharmacokinetics and relative bioequivalence of domestic and imported indinavir sulfate capsules.METHODS:A single oral dose of 800mg domestic indinavir sulfate capsules(the test preparation)and the imported ones(the reference preparation)were given to 20 healthy male volunteers in a randomized crossover design.The plasma concentrations of indinavir were determined by HPLC method.RESULTS:The main pharmacokinetic parameters of the test and reference preparations were as follows:Cmax were(13.51±3.23)mg/L and(13.14 ±3.92)mg/L respectively ;tmax were(0.63±0.17)h and(0.63±0.18)h respectively;AUC0～8 were(23.62±7.27)(mg·h)/L and(23.02±6.24)(mg·h)/L respectively;t1/2 were(1.2±0.5)h and(1.2±0.4)h,respectively.The relative bioavailability of the test preparation was(99.2±13.9)%.CONCLUSION:There are no significant differences(P>0.05)in the main pharmacokinetic parameters between the domestic preparation and the imported preparation,which suggests they are bioequivalent.