Yung Shin Pharm Ind Kunshan Co. Ltd.

Healthy Chinese subjects were used as test subjects. A self-crossover design was used to determine the time course of doxycycline concentration in plasma after administration of doxycycline hydrochloride tablets produced by Dequan Pharmaceutical (Jiangsu) Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Doxycycline hydrochloride tablets produced by Pfizer Japan Inc. under a license [trade name: Vibramycin, specification: 100 mg (calculated as C22H24NO8)] were used as reference to evaluate the bioequivalence between the preparations and to observe the safety of doxycycline hydrochloride tablets in healthy Chinese subjects.

Primary objective: To compare the differences in absorption extent and absorption rate between valacyclovir hydrochloride tablets (trade name: VALTREX®/Valtrex®, specification: 0.5 g) produced by Dequan Pharmaceutical (Jiangsu) Co., Ltd. and valacyclovir hydrochloride tablets (specification: 0.5 g) produced by Glaxo Wellcome SA under the license of The Wellcome Foundation Limited in healthy Chinese people by using a single-center, randomized, open, two-period, self-crossover, single-dose fasting/postprandial administration design, and to evaluate bioequivalence. Secondary objective: To evaluate the safety of the test and reference preparations of valacyclovir hydrochloride tablets (specification: 0.5 g) in healthy subjects.