Beijing Wanhui Double-Crane Pharmaceutical Co. Ltd.

Main study purpose: According to the relevant provisions of bioequivalence test, baricitinib tablets (trade name: Olumiant®, specification: 2mg) with Eli Lilly Nederland B.V. as the licensee were selected as the reference preparation, and the test preparation baricitinib tablets (specification: 2mg) produced and provided by China Resources Double Crane Pharmaceutical Co., Ltd. were used for fasting 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 conditions. Secondary study purpose: To observe the safety of oral administration of the test preparation baricitinib tablets (specification: 2mg) and the reference preparation baricitinib tablets (trade name: Olumiant®, specification: 2mg) in healthy subjects.

To investigate the pharmacokinetic characteristics of a single oral dose of baricitinib tablets (test preparation T, strength: 2 mg) provided by China Resources Double Crane Pharmaceutical Co., Ltd. and a single oral dose of baricitinib tablets (reference preparation R, trade name: Olumiant®, strength: 2 mg) certified by Eli Lilly Nederland B.V. in healthy study participants in the postprandial state, to compare the differences in pharmacokinetic parameters AUC and Cmax between the two preparations, and to preliminarily evaluate the bioequivalence of the two preparations.

To study the pharmacokinetic characteristics of a single oral administration of baricitinib tablets (test preparation T, strength: 2 mg) provided by China Resources Double Crane Pharmaceutical Co., Ltd. and a single oral administration of baricitinib tablets (reference preparation R, trade name: Olumiant®, strength: 2 mg) certified by Eli Lilly Nederland B.V. in healthy subjects in the fasting state, compare the differences in pharmacokinetic parameters AUC and Cmax between the two preparations, and preliminarily evaluate the bioequivalence of the two preparations.