Pharmacokinetics and Bioequivalence of Mycophenolate Mofetil Dispersible Tablets in Healthy Volunteers
SHI Shao-jun1a，LI Zhong-fang1b，WAN Yuan-sheng1a，CHEN Hua-ting1a，ZENG Fan-dian2
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1a. Department of Pharmacy[ 1b.Department of Obstetrics and Gynecology，Union Hospital Affiliated to Tongji Medical College，Huazhong University of Science and Technology，Wuhan 430022，China[ 2.Institute of Clinical Pharmacology，Tongji Medical College，Huazhong University of Science and Technology，Wuhan 430030，China
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History+
Received
Published
2007-05-21
2008-05-10
Issue Date
2008-05-10
Abstract
OBJECTIVE To study the pharmacokinetics and relative bioavailability of mycophenolate mofetil(MMF) dispersible tablets in healthy volunteers and to evaluate the bioequivalence.METHODS A single oral dose of 1.0 g MMF test dispersible tablets and reference capsules was given to 20 male healthy volunteers in a randomized,two-way crossover study.Mycophenolic acid(MPA),the active constitute of MMF was determined by RP-HPLC method.The pharmacokinetic parameters and relative bioavailability were calculated with DAS software to evaluate the bioequivalence of the two preparations.RESULTS The main pharmacokinetic parameters of test and reference preparations were as follows:t1/2 were(16.26±3.79) and(16.85±3.97)h;tmax were(0.67±0.22) and(0.78±0.29)h;ρmax were(24.07±7.04)and(25.58±9.02)mg·L-1;AUC0-48 were(56.84±12.81)and(59.06±15.96)mg·h·L-1;AUC0-∞ were(62.25±12.63)and(64.58±15.28)mg·h·L-1,respectively.The differences of the major pharmacokinetic parameters between test and reference tablets were not significant.The relative bioavailability of F0-48 was(97.95±13.73)%.CONCLUSION The statistical analysis of the results show that the two preparations are bioequivalent.
SHI Sho-jun;LI Zhong-fng;WN Yun-sheng;CHEN Hu-ting;ZENG Fn-din.
Pharmacokinetics and Bioequivalence of Mycophenolate Mofetil Dispersible Tablets in Healthy Volunteers [J]. Chinese Pharmaceutical Journal, 2008, 43(10): 776-778
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