Anhui Fengyuan Pharmaceutical Co., Ltd.

Ethambutol hydrochloride tablets (trade name: Ebutol, specification: 250mg) produced by licensed manufacturer Kaken Pharmaceutical Co., Ltd. were used as reference preparations, and ethambutol hydrochloride tablets (specification: 0.25g) provided by Bengbu Fengyuan Tushan Pharmaceutical Co., Ltd. were used as test preparations. A randomized, open, single-dose, two-period double crossover design was used to evaluate the bioequivalence of the two preparations in fasting and postprandial states in healthy Chinese subjects. The safety of the oral test preparation ethambutol hydrochloride tablets (specification: 0.25g) and the reference preparation (trade name: Ebutol, specification: 250mg) in healthy Chinese subjects was evaluated.

Vonoprazan fumarate tablets (specification: 20 mg) developed by Bengbu Fengyuan Tushan Pharmaceutical Co., Ltd. were used as the test preparation, and Vonoprazan fumarate tablets (trade name: Walker®/Vocinti®, specification: 20 mg) produced by Takeda Pharmaceutical Company Limited were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations were investigated after single administration in the fasting and postprandial states, and whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

According to the relevant provisions of bioequivalence test, Rifampicin Capsules (Specification: 150mg, Trade Name: Rifadin) produced by Sanofi S.P.A. of Italy were selected as the reference preparation, and the test preparation Rifampicin Capsules (Specification: 0.15g) produced by Bengbu Fengyuan Tushan Pharmaceutical Co., Ltd. were subjected to a human bioequivalence test on fasting administration. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see whether they were within an acceptable range, and the bioequivalence of the two preparations under fasting administration conditions was compared.