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《The Chinese Journal of Clinical Pharmacology》 2002-02
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Study of the Pharmacokinetics and Bioequivalance of Ornidazole Capsules andImported Ornidazole Tablets in Healthy Volunteers

LI Qin1WANG Ben-Jie2GUO Rui-Chen21(Dept. of Pharmacology,Liaocheng People Hospital,Liaocheng, 252000)2(Institute of ClinicalPharmacology, Qilu Hospital,Shandong University, Jinan,250012)  
OBJECTIVE:To study the pharmacokinetic profiles and bioequivalenceof ornidazole in healthy volunteers. METHODS: l.5g single oral dose of domesticornidazole capsules and imported ornidazole tablets were given to l8 healthyvolunteers in an open randomized crossover. Ornidazole concentrations in plasmawere determined by HPLC method. The pharmacokinetic parameters as well asrelative bioavailability were measured. RESULTS: The concentration-time curves ofcapsules and tablets ornidazole were conformed to a two-compartment model witha lag time. The pharmacokinetic parameters of capsules and tablets ornidazole wereas follows:t(1/2)(β),were l6.08±2.32h and l5.85±2.26h;Tmax were l.75±0.49h andl.75±0.48h;Cmax were 2l.94±3.3lmg.L-1 and 22.58±5.94 mg.L-1;AUC0~∞ were 456.22±446.50±55.l4mg.h.L-1 and 433.3l±58.52 mg.h.L-1;AUC0~∞co were 465.22±56.73mg.h.L-1and 45l .67±57.97mg.h.L-1, respectively. There were nosignificant difference between the two formulations (P0.05). The relativebioavailability of ornidazole capsule was l03.52%±6.59%. CONCLUSION: Theresult of the statistical analysis showed that the two formulations werebioequivalent.
【CateGory Index】: R969
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