Shanxi Xinbaoyuan Pharmaceutical Co., Ltd.

This study investigates whether there are differences in the absorption rate and extent between a single oral dose of the test formulation estazolam tablets (Shanxi Shuangyan Pharmaceutical Co., Ltd., specification: 1 mg) and the reference formulation estazolam tablets (trade name: EURODIN®; Teva Takeda Yakuhin Ltd./武田テバ薬品株式会社, specification: 1 mg) after a meal in healthy study participants. It also evaluates the bioequivalence of the test and reference formulations when administered after a meal and observes their safety in healthy study participants.

This study investigates whether there are differences in the absorption rate and extent between the test formulation estazolam tablets (Shanxi Shuangyan Pharmaceutical Co., Ltd., specification: 1mg) and the reference formulation estazolam tablets (trade name: EURODIN®; Teva Takeda Yakuhin Ltd./武田テバ薬品株式会社, specification: 1mg) administered orally to healthy study participants on an empty stomach. It also evaluates the bioequivalence of the test and reference formulations when administered on an empty stomach and observes their safety in healthy study participants.

Main study objectives Healthy subjects were given a single oral dose of the test preparation nifedipine controlled-release tablets (specification: 90 mg) produced by Shanxi Xinbaoyuan Pharmaceutical Co., Ltd. or the reference preparation nifedipine controlled-release tablets (trade name: PROCARDIA XL®; specification: 90 mg) produced by Pfizer Laboratories Div Pfizer Inc. in the fasting or postprandial state to investigate the pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects, respectively, and to evaluate the bioequivalence of the two preparations. Secondary study objectives Investigate the safety of the test preparation and the reference preparation in healthy subjects.