Beijing Wanhui Double-Crane Pharmaceutical Co. Ltd.

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.

Main research purpose: According to the relevant provisions of bioequivalence test, the amlodipine benazepril capsules (trade name: Lotrel, specifications: 5mg: 10mg) of Novartis Pharmaceuticals Corp. as the licensee were selected as the reference preparation, and the human bioequivalence test of the test preparation amlodipine benazepril capsules (specifications: 5mg: 10mg) produced by China Resources Double Crane Pharmaceutical Co., Ltd. was conducted on fasting and postprandial administration 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 compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation amlodipine benazepril capsules (specifications: 5mg: 10mg) and the reference preparation amlodipine benazepril capsules (trade name: Lotrel, specifications: 5mg: 10mg) in healthy volunteers.