Anhui Fengyuan Pharmaceutical Co., Ltd.

This trial aims to study the pharmacokinetic characteristics of ibrutinib capsules (140 mg) developed by Bengbu Fengyuan Tushan Pharmaceutical Co., Ltd. and produced by Beijing Yabao Biopharmaceutical Co., Ltd. after a single oral dose after meal; using ibrutinib capsules (Yike®, 140 mg) produced by Catalent CTS LLC as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, the human bioequivalence of the two preparations was evaluated, and the safety of the two preparations in healthy study participants was observed.

This trial aims to study the pharmacokinetic characteristics of a single fasting oral dose of ibrutinib capsules (140 mg) developed by Bengbu Fengyuan Tushan Pharmaceutical Co., Ltd. and produced by Beijing Yabao Biopharmaceutical Co., Ltd.; using ibrutinib capsules (Yike®, 140 mg) produced by Catalent CTS LLC as the reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, evaluate the human bioequivalence of the two preparations, and observe the safety of the two preparations in healthy study participants.

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.