Yang Zi Jiang Yao Ye Si Chuan Hai Rong Yao Ye You Xian Gong Si

The study used healthy volunteers as test subjects and adopted a randomized, open, two-preparation, two-period, two-sequence, crossover design to investigate the in vivo time course of tadalafil after a single oral administration of the test preparation and the reference preparation on an empty stomach in healthy subjects, estimate its relevant pharmacokinetic parameters and relative bioavailability, and evaluate its bioequivalence in the fasting state, so as to provide a basis for the safe and rational use of the test preparation.

The study used healthy volunteers as test subjects and adopted a randomized, open, two-preparation, two-period, two-sequence, crossover design to investigate the in vivo time course of tadalafil after a single oral administration of the test preparation and the reference preparation to healthy subjects after a meal, estimate the relevant pharmacokinetic parameters and relative bioavailability, and evaluate the bioequivalence in the postprandial state, so as to provide a basis for the safe and rational use of the test preparation.

Primary objective: To study the pharmacokinetic behavior of the test formulation of vonoprazan fumarate tablets (specification: 20 mg, Yangtze River Pharmaceutical Group Sichuan Hairong Pharmaceutical Co., Ltd.) and the reference formulation (Takecab?, specification: 20 mg, Takeda Pharmaceutical Company Limited) in healthy Chinese subjects after a single oral administration in the fasting or postprandial state, and to evaluate the bioequivalence of the two formulations. Secondary objective: To observe the safety of the test formulation and the reference formulation (trade name: Takecab) in healthy Chinese subjects.