Zhengzhou Demai Pharmaceutical Co., Ltd.

Main objective: This study aimed to investigate the pharmacokinetic characteristics of fenelazol tablets (10 mg) developed and manufactured by Zhengzhou Demai Pharmaceutical Co., Ltd., after a single oral fasting dose. Using fenelazol tablets (Keshenda®, 10 mg) manufactured by Bayer AG as the reference formulation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate their bioequivalence in humans.

Primary objective: To study the pharmacokinetics of apalutamide tablets (60 mg, manufactured by Zhengzhou Demai Pharmaceutical Co., Ltd.) and reference apalutamide tablets (Ansenke®, 60 mg, manufactured by Janssen Ortho, LLC) in healthy participants after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. Secondary objective: To evaluate the safety of apalutamide tablets (60 mg, manufactured by Zhengzhou Demai Pharmaceutical Co., Ltd.) and reference apalutamide tablets (Ansenke®, 60 mg) in healthy participants.

Primary objective: To investigate the in vivo pharmacokinetic characteristics of single-dose oral administration of neratinib maleate tablets (specification: 40 mg/tablet) from Zhengzhou Demai Pharmaceutical Co., Ltd. and neratinib maleate tablets (specification: 40 mg/tablet) from Puma Biotechnology Inc., a licensee, in healthy Chinese subjects under fasting/postprandial conditions through fasting/postprandial test studies, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of single-dose oral administration of neratinib maleate tablets 240 mg (6 tablets, specification: 40 mg/tablet) and reference preparations in healthy Chinese subjects.