1.Department of Clinical Pharmacology，First Affiliated Hospital，Medical College，Zhejiang University，Hangzhou 310003，China；2.Zhejiang Institute for Drug Control，Hangzhou 310016，China
OBJECTIVE To evaluate the bioequivalence of domestic and imported indinavir capsule in the healthy volunteers. METHODS A single oral dose of 800 mg test or reference preparations of indinavir was given to 18 healthy volunteers in a randomized crossover study. The indinavir serum concentrations were determined by HPLC-MS assay.RESULTS The main pharmacokinetic parameters of the two products were as follow: tmax(0.61±0.22)and(0.60±0.19)h;ρmax(15.66±4.24)and(15.99±4.29)mg·L-1; AUC0～10(34.25±8.95)and (33.40±7.56)mg·h·L-1;t1/2(ke)(1.35±0.34) and(1.32±0.39)h,respectively.The relative bioavailability of the test to reference capsule was (98.81±12.05) % .CONCLUSION The variance analysis and two one-side t test show that the two formulations are bioe-quivalent.
SHENG-TU Jin-zhong;LU Xio-yng;ZHOU Hui-li;ZHENG Guo-gng;CHEN Zhi-gen;HUNG Ming-zhu;SHI Mei-fu.
Studies on Bioequivalence of Indinavir Capsule in Healthy Volunteers [J]. Chinese Pharmaceutical Journal, 2006, 41(02): 126-128
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参考文献
[1] ZENG J E. Biomedicine Analyse(生物药物分析)[M] .2nd ed. Beijing：Beijing medical university/Peking union medical college of China united press.1998：230.
[2] REMMEL R P， KAWLE S P， WEJLLER D，et al. Simultaneous HPLC assay for quantification of indinavir， nelfinavir， ritonavir，and saquinavir in human plasma[J] .Clin Chem，2000，46(1)：73.
[3] ZHONG L， YEH K C. Determination of indinavir in human cerebrospinal fluid and plasma by solid-phase extraction and high-performance liquid chromatography with column switching[J] .J Chromatogr B Biomed Sci Appl，1999，734(1)：63.
[4] YEH K C，DEUTSCH P J，HADDIX H，et al. Single-dose pharmacokinetics of indinavir and the effect of food[J] .Antimicrob Agents Chemother，1998，42(2)：332.
[5] HSU A，GRANNEMAN G R，CAO G，et al. Pharmacokinetic interaction between ritonavir and indinavir in healthy volunteers[J] .Antimicrob Agents Chemother，1998， 42(11)：2784.
[6] BENET L Z，CUMMINS C L，WU C Y.Unmasking the dynamic interplay between efflux transporters and metabolic enzymes[J] .Int J Pharm，2004，277(1-2)：3.
