China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.

Primary Objective: To investigate the pharmacokinetic parameters and intra-individual coefficients of variation of merogalline besylate orally disintegrating tablets (test formulation T, manufactured by CR Double-Crane Pharmaceutical (Jinan) Co., Ltd., specification: 10 mg/tablet) and merogalline besylate orally disintegrating tablets (reference formulation R, licensed by Daiichi Sankyo Co., Ltd., trade name: Tarlige®, specification: 10 mg/tablet) in healthy participants under fasting/postprandial conditions, following oral administration of a single dose. This also aims to validate the rationality of the blood drug concentration analysis methods, blood collection time, and washout interval settings. Secondary Objective: To observe the safety of the test and reference formulations in healthy participants.

Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation utpatinib extended-release tablets (15 mg, C17H19F3N6O; certified by CR Double-Crane Pharmaceutical (Jinan) Co., Ltd.) and the reference formulation utpatinib extended-release tablets (Ruifa®, 15 mg, C17H19F3N6O; certified by AbbVie Deutschland GmbH & Co. KG) in healthy adult participants under both fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations under fasting and postprandial conditions. Secondary objective: To evaluate the safety of the test formulation utpatinib extended-release tablets (15 mg, C17H19F3N6O) and the reference formulation utpatinib extended-release tablets (Ruifa®, 15 mg, C17H19F3N6O) in healthy adult participants.

Primary research objective: In accordance with relevant bioequivalence testing regulations, domenorrhea tablets (trade name: Ulexi, strength: 2mg), manufactured by FUJI YAKUHIN CO., LTD., a licensee, were selected as the reference formulation. A preliminary human bioequivalence study was conducted on domenorrhea tablets (strength: 2mg), manufactured by and supplied by CR Double-Crane Limin Pharmaceutical (Jinan) Co., Ltd., under fasting and postprandial administration. The pharmacokinetic characteristics of the test and reference formulations after fasting and postprandial administration were estimated to provide a reference for the design of the formal trial. Secondary research objective: To observe the safety of oral administration of the test and reference formulations, domenorrhea tablets (strength: 2mg), to healthy participants.