Anhui Baker Biopharmaceutical Co., Ltd.

This study investigated the pharmacokinetic characteristics of the test formulation (emtricitabine and tenofovir alafenamide tablets (II), each tablet containing 200 mg emtricitabine and 25 mg tenofovir alafenamide, licensed by Anhui Baker Biopharmaceutical Co., Ltd.) and the reference formulation (emtricitabine and tenofovir alafenamide tablets (II), each tablet containing 200 mg emtricitabine and 25 mg tenofovir alafenamide, trade name Descovy, licensed by Gilead Sciences, Inc.) in participants under fasting conditions, compared the bioequivalence of the test and reference formulations, and studied the safety of the drugs in participants.

Primary Objective: Using baricitinib tablets developed by Anhui Baker Biopharmaceutical Co., Ltd. as the test formulation and baricitinib tablets (trade name: Olumiant®) licensed by Japan Ilairiri Co., Ltd. as the reference formulation, we investigated the pharmacokinetic parameters and relative bioavailability of the two formulations after single administration in the fasting and fed states, and evaluated their bioequivalence. Secondary Objective: To evaluate the safety of the test and reference formulations of baricitinib tablets after single oral administration in healthy Chinese participants, both in the fasting and fed states.

Main purpose: This study uses the test preparation of Aguratimod tablets (specification: 25 mg) of Anhui Baker Biopharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, the original manufacturer Hainan Xiansheng Pharmaceutical Co., Ltd. holds Aguratimod tablets (specification: 25 mg, trade name: Edexin®) as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary purpose: Observe the safety of the test preparation Aguratimod tablets and the reference preparation Aguratimod tablets (Edexin®) in healthy subjects.