Shanghai Xinyi Bailuda Pharmaceutical Co. Ltd.

The doxazosin mesylate sustained-release tablets produced by Shanghai Xinyi Bailuda Pharmaceutical Co., Ltd. were used as the test preparation, and the doxazosin mesylate sustained-release tablets (trade name: Keduohua®) produced by the licensee Viatris Pharma GmbH were used as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior of the two preparations in healthy Chinese subjects was compared to evaluate the bioequivalence of the two preparations. The safety of the test preparation and the reference preparation after a single oral administration on an empty stomach or after a meal was evaluated in healthy Chinese subjects.

Primary objective: To study the pharmacokinetic characteristics of upadacitinib sustained-release tablets [test preparation T, specification: 15 mg (in C17N19F3N6O)] produced by Shanghai Xinyi Bio-Tech Pharmaceutical Co., Ltd. and upadacitinib sustained-release tablets [reference preparation R, specification: 15 mg (in C17N19F3N6O), trade name: Ruifu®] produced by AbbVie Ireland NL B.V. in healthy subjects in fasting and postprandial state, and to evaluate the bioequivalence between the two preparations. Secondary objective: To evaluate the safety of single oral administration of test preparation upadacitinib sustained-release tablets [15 mg (in C17N19F3N6O)] and reference preparation upadacitinib sustained-release tablets [Rufu®, 15 mg (in C17N19F3N6O)] in healthy Chinese adult subjects in fasting and postprandial state.

The pharmacokinetic behavior of the test formulation of Olmesartan Medoxomil Amlodipine Tablets (specifications: Olmesartan Medoxomil 20 mg; Amlodipine Besylate 5 mg (calculated as amlodipine), produced by Shanghai Xinyi Bio-Pharmaceutical Co., Ltd.) and the reference formulation (trade name: Sevikar®, specifications: Olmesartan Medoxomil 20 mg; Amlodipine Besylate 5 mg (calculated as amlodipine), Daiichi Sankyo as the licensee) in healthy subjects after a single oral dose in the fasting and postprandial states was studied to evaluate the bioequivalence of the two formulations.