Abstract
OBJECTIVE To study the pharmacokinetics and relative bioavailability of tropisetron hydrochloride capsules in healthy volunteers and to evaluate the bioequivalence.METHODS A single dose of 10 mg reference and test tropisetron capsules was given to 18 healthy volunteers in a randomized 2-way cross-over study.The concentrations of tropisetron hydrochloride in plasma were determined by RP-HPLC-UV.RESULTS The main pharmacokinetic parameters of two formulations,reference and test drug were as follows:tmax(1.86±0.43) and(2.03±0.52)h,ρmax(11.73±3.05) and(11.25±3.30) μg·L-1,AUC0~24(111.89±39.86) and(113.61±40.34) μg·h·L-1;AUC0-inf(139.71±60.35) and(142.22±57.34) μg·h·L-1,t1/2(kα)(0.79±0.29) and(0.82±0.25)h;t1/2(ke)(5.08±1.92) and((5.48±2.08)) h,Ke(0.16±0.06) and(0.14±0.05) h-1,respectively.The relative bioavailability of AUC0~24 and AUC0-inf were(98.55±10.37)% and(99.77±18.66)%.Using 3P97 program,the results of variance and two one-sided test statistical analysis for Lnρmax,LnAUC0~24 and LnAUC0-inf showed that two formulations were bioequivalent.CONCLUSION The reference and test tropisetron capsules are bioequivalent.
Key words
tropisetron hydrochloride /
pharmacokinetics /
bioequivalence /
HPLC
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FU Ling-qing;HUNG Feng;TNG Xin;QIN Ping-li;LIU Ze-yun.
Pharmacokinetic and Bioequivalence Study of Tropisetron Chlorate Capsule in Human [J]. Chinese Pharmaceutical Journal, 2006, 41(04): 293-295
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