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《The Chinese Journal of Clinical Pharmacology》 2003-06
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Relative bioavailability and bioequivalance of troxipide capsule in healthy volunteers after a single oral administration

ZHAO Ya-nan, QIU Fu-rong, WANG Wei-jia, SUN Hua, DAI Min, YANG Qing-qing, MAO Guo-guang (National Drug Clinical Research Base, Yijishan Hospital, Wannan Medical College, Wuhu 241001, China)  
Objective To study the pharmacokinetics and relative bioavailability of troxipide capsule. Methods A single oral dose of 100 mg troxipide capsule (test group) and tablet (control group) were given to 18 healthy volunteers in an open randomized crossover design. The concentrations in plasma were determined by reverse phase HPLC method. Results The main pharmacokinetic parameters were as follow: t1/2ke were 6.52 ± 1.62 and 7.03 ± 2.27 h, tmax were 2.89 ± 0.93 and 2.97 ± 1.25 h, Cmax were 0.98 ± 0.27 and 1.06 ±0.31 mg.L-1, AUC0-24 were 15.18 ± 4.11 and 15.96± 3.97 mg.h.L-1, AUC0- were 15.83 ± 4.12 and 16.82 ± 4.47 mg .h .L-1 for test and control, respectively. Conclusion The results of statistics analysis demonstrated that two formulations were bioequivalent.
【CateGory Index】: R96
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