Shijiazhuang Huaxin Pharmaceutical Co., Ltd.

Using pharmacokinetic parameters as the primary endpoint, the pharmacokinetic behavior of the test formulation thioctic acid tablets (0.6g, licensee: Shijiazhuang Huaxin Pharmaceutical Co., Ltd.) and the reference formulation thioctic acid tablets (0.6g, licensee: Viatris Healthcare GmbH, trade name: Thioctacid®) in healthy trial participants under fasting conditions was compared to evaluate the bioequivalence of the two formulations.

This study investigated the pharmacokinetic characteristics of roxadustat tablets (50 mg) manufactured by Shijiazhuang Huaxin Pharmaceutical Co., Ltd., and roxadustat capsules (trade name: Erexor®, 50 mg) manufactured by FibroGen (China) Pharmaceutical Technology Development Co., Ltd., under fasting/postprandial conditions in Chinese health trial participants to evaluate the bioequivalence of the two formulations.

Primary Objective: To investigate the similarity of pharmacokinetic characteristics between atorvastatin calcium tablets (20 mg) manufactured by Shijiazhuang Huaxin Pharmaceutical Co., Ltd. and those manufactured by Huizhi Pharmaceutical (Dalian) Co., Ltd., through a small-sample pharmacokinetic study. This will provide a basis for decision-making regarding whether to proceed to the formal trial. Simultaneously, it will examine intra-individual variability of the drug, providing evidence for determining the sample size, blood collection points, and analytical methods for the formal trial. Secondary Objective: To evaluate the safety of a single oral dose of atorvastatin calcium tablets (20 mg) in healthy participants, comparing the test and reference formulations.