Anhui Ailide Pharmaceutical Co., Ltd.

Main study purpose: According to the relevant provisions of bioequivalence test, dronedarone hydrochloride tablets (trade name: Maidalong®, specification: 400mg) of which Sanofi Aventis U.S., LLC is the licensee was selected as the reference preparation, and the test preparation dronedarone hydrochloride tablets (specification: 400mg) produced by Anhui Aili Pharmaceutical Co., Ltd. and provided by Jiangsu Ailikang Pharmaceutical Technology Co., Ltd. were subjected to human bioequivalence test for 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 study purpose: To observe the safety of oral administration of the test preparation dronedarone hydrochloride tablets (specification: 400mg) and the reference preparation dronedarone hydrochloride tablets (trade name: Maidalong®, specification: 400mg) in healthy subjects.

To investigate the pharmacokinetic characteristics of healthy subjects under fasting conditions, when taking a single oral dose of 1 tablet of butylphthalide soft capsule (test preparation, specification: 0.1g) provided by Anhui Ailede Pharmaceutical Co., Ltd. and a single oral dose of 1 tablet of butylphthalide soft capsule (reference preparation, trade name: Enbipu®, specification: 0.1g) produced by CSPC Pharmaceutical Group Enbipu Pharmaceutical Co., Ltd., and evaluate the bioequivalence and safety of the two preparations, so as to provide a basis for the registration application of the test preparation.

Main research purpose: According to the relevant provisions of bioequivalence test, Pfizer Inc.'s tofacitinib citrate sustained-release tablets (trade name: Xeljanz® (Shangjie), specification: 11mg) were selected as the reference preparation. The test preparation tofacitinib citrate sustained-release tablets (specification: 11mg) produced by Anhui Aili Pharmaceutical Co., Ltd. was subjected to human bioequivalence test for fasting and postprandial administration. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see if they were within the acceptable range. The bioequivalence of the two preparations under fasting and postprandial administration conditions was compared. Secondary research purpose: To observe the safety of oral administration of the test preparation tofacitinib citrate sustained-release tablets (specification: 11mg) and the reference preparation tofacitinib citrate sustained-release tablets (trade name: Xeljanz® (Shangjie), specification: 11mg) by healthy volunteers.