Zhejiang Zhebei Pharmaceutical Co. Ltd.

The primary study objective was to investigate the relative bioavailability of the test formulation, Rosuvastatin Ezetimibe Tablets (I) [Specification: Each tablet contains 10 mg of rosuvastatin calcium (calculated as rosuvastatin) and 10 mg of ezetimibe, manufactured by Anhui Jiahe Pharmaceutical Co., Ltd.], compared with the reference formulation, Rosuvastatin Ezetimibe Tablets (I) [Specification: Each tablet contains 10 mg of rosuvastatin calcium (calculated as rosuvastatin) and 10 mg of ezetimibe, licensed by Sanofi-Aventis Ireland Limited T/A SANOFI], in healthy Chinese adults after a single oral fasting/fed dose. The pharmacokinetic parameters of the two formulations were analyzed, and the bioequivalence of the two formulations was evaluated. The secondary study objective was to evaluate the safety of the test formulation and the reference formulation in healthy Chinese adults after a single oral fasting/fed dose.

Main study purpose: According to the relevant provisions of bioequivalence test, the valacyclovir hydrochloride tablets (trade name: Valtrex; specification: 0.5g (calculated as valacyclovir)) certified by The Wellcome Foundation Limited were selected as the reference preparation, and the test preparation valacyclovir hydrochloride tablets (specification: 0.5g (calculated as valacyclovir)) produced and provided by Zhejiang Zhebei Pharmaceutical Co., Ltd. were subjected to fasting and postprandial human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary study purpose: To observe the safety of oral administration of the test preparation valacyclovir hydrochloride tablets (specification: 0.5g (calculated as valacyclovir)) and the reference preparation valacyclovir hydrochloride tablets (trade name: Valtrex; specification: 0.5g (calculated as valacyclovir)) in healthy subjects.

The main purpose of the study is to investigate the pharmacokinetic characteristics of a single oral dose of 0.75 μg of the test preparation edircitol soft capsule (specification: 0.75 μg/capsule, produced by Zhejiang Zhebei Pharmaceutical Co., Ltd.) and the reference preparation edircitol soft capsule (trade name: EDIROL®, specification: 0.75 μg/capsule, produced by Chugai Pharmaceutical Co., Ltd.) in healthy adult Chinese subjects under fasting/fed conditions, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting and fed states, respectively. Secondary study objective: To evaluate the safety of a single oral dose of 0.75 μg of the test formulation and the reference formulation under fasting/fed conditions in healthy adult Chinese subjects.