Kunshan Rotam Reddy Pharmaceutical Co. Ltd.

Primary objective: To investigate the in vivo pharmacokinetic characteristics of apalutamide tablets (specification: 60 mg) produced by Kunshan Longdeng Redi Pharmaceutical Co., Ltd. and apalutamide tablets (trade name: Erleada®/Ansenke®, specification: 60 mg) approved by Janssen-Cilag International NV in healthy Chinese male subjects after a single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test and reference preparations of apalutamide tablets after a single oral administration in healthy Chinese male subjects.

Main study objectives: To study the pharmacokinetic characteristics of baricitinib tablets (test preparation, specification: 4 mg) developed by Kunshan Longdeng Redi Pharmaceutical Co., Ltd. and baricitinib tablets (reference preparation, trade name: Olumiant®, specification: 4 mg) licensed by Eli Lilly Nederland B.V. in healthy Chinese subjects according to the relevant provisions of bioequivalence studies, and to evaluate the bioequivalence of the two preparations in the fasting state and the fed state. Secondary study objectives: To observe the safety of the test preparation (specification: 4 mg) and the reference preparation (trade name: Olumiant®, specification: 4 mg) of baricitinib tablets in healthy Chinese subjects.

Main purpose of study: This study uses Tilolisen hydrochloride tablets (specification: 18 mg) produced by Dr. Reddy's Laboratories Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, Tilolisen hydrochloride tablets (specification: 18 mg, trade name: Huakesi®) certified by Bioprojet Pharma and produced by Inpharmasci are used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary purpose of study: To observe the safety of the test preparation Tilolisen hydrochloride tablets and the reference preparation Tilolisen hydrochloride tablets (Huakesi®) in healthy subjects.