Henan Taifeng Biotechnology Co., Ltd.

Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behaviors of the test preparation ulipristal acetate tablets provided by Henan Taifeng Biotechnology Co., Ltd. and the reference preparation ulipristal acetate tablets (manufacturer: Gedeon Richter Plc, trade name: Esmya®) in healthy female subjects after oral administration in the fasting/postprandial state were compared to evaluate the bioequivalence of the two preparations.

The pharmacokinetics of the test preparation, edicalcitol soft capsule (specification: 0.75 μg, produced by Henan Taifeng Biotechnology Co., Ltd.) and the reference preparation, edicalcitol soft capsule (Edirol®, specification: 0.75 μg; produced by Chugai Pharmaceutical Co., Ltd.) were studied in healthy subjects after a single oral administration in the fasting and fed state, and the bioequivalence of the two preparations after oral administration in the fasting and fed state was evaluated.

The main purpose of the study is to evaluate the pharmacokinetic characteristics of the test preparation Palonosetron Hydrochloride Soft Capsules (Specification: 0.5 mg, licensee: Henan Taifeng Biotechnology Co., Ltd.) and the reference preparation Palonosetron Hydrochloride Soft Capsules (Aloxi®, Specification: 0.5 mg, licensee: Helsinn Birex Pharmaceuticals Ltd.) in healthy subjects 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 purpose of the study is to evaluate the safety of the test preparation Palonosetron Hydrochloride Soft Capsules (Specification: 0.5 mg) and the reference preparation Palonosetron Hydrochloride Soft Capsules (Aloxi®, Specification: 0.5 mg) in healthy subjects.