Pharmacokinetics and relative bioavailability of valaciclovir hydrochloride tablets in Chinese healthy volunteers

    HU Xiao, ZHANG Hong, XIA ChunHua, CHEN YueJiang

    Institute of Clinical Pharmacology, Jiangxi Medical College, Nanchang 330006, China

    【Abstract】 AIM: To study the pharmacokinetics and relative bioavailability of valaciclovir hydrochloride tablets and evaluate its bioequivalence. METHODS: A single oral dose 600 mg of 2 valaciclovir hydrochloride tablets was given to 18 healthy volunteers in an open randomized crossover study. The concentration of acyclovir in plasma was determined by HPLC at different time points within 14 h following administration. The pharmacokinetic parameters were calculated by BAPP 2.0 software and the bioequivalence was evaluated by two onesided t test and 90%confidence intervals. RESULTS: The calibration curve of acyclovir was linear in the range of 0.1~4.0 μg/mL (r=0.9999), and an intraday and interday RSD of<7.00% was observed. The concentrationtime curve after administration was best fitted to a one compartment open model, and main pharmacokinetic parameters were as follows: Tmax were (1.50±0.40) and (1.40±0.40) h; Cmax were (2.70±0.68) and (2.87±0.75) μg/mL; t1/2 were (3.00±0.65) and (3.28±0.67) h; AUC0-14 were 9.07±2.43 and 9.71±2.70 μg·h/mL. The relative bioavailability of the test preparations compared with the reference preparations was (96.4±23.7)%. There was no statistically singnificant difference in parameters Tmax, t1/2, Cmax, MRT, AUC0-14 and AUC0-∞ between the 2 products (P>0.05). CONCLUSION: The 2 valaciclovir hydrochloride tablets were bioequivalent. ...... 如果您在使用手机等流览时无法查看或下载全文，可能是被搜索引擎失真“转码”，请点击屏幕最下方的“电脑版”或“原网页”访问。


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