Zhejiang Pharmaceutical Co. Ltd. Xinchang Pharmaceutical Factory

To evaluate the safety, tolerability, and pharmacokinetic characteristics of XC2309 tablets after single and multiple administration in healthy subjects; to evaluate the pharmacokinetic characteristics of XC2309 tablets in healthy subjects in the fasting and postprandial states, and to evaluate the effect of food on the pharmacokinetic characteristics; to evaluate the pharmacodynamic characteristics of XC2309 tablets after single and multiple administration in healthy subjects, and to provide a basis for dose selection in later clinical studies; to explore and identify the main metabolites in the human body after a single administration of XC2309 tablets in healthy subjects.

To evaluate the clinical, microbiological efficacy and safety of nemofloxacin malate capsules in the treatment of uncomplicated urinary tract infection using levofloxacin tablets as a positive control, to understand the population pharmacokinetic (PPK) characteristics of continuous oral administration of nemofloxacin malate in patients with uncomplicated urinary tract infection, to conduct pharmacokinetic (PK)/pharmacodynamic (PD) analysis and to evaluate the dosing regimen.

Testosterone undecanoate soft capsules (specification: 40 mg) produced by Xinchang Pharmaceutical Factory of Zhejiang Medicine Co., Ltd. were used as the test preparation, and testosterone undecanoate soft capsules (trade name: Antel®, specification: 40 mg) produced by the licensee N.V. Organon and manufactured by Catalent France Beinheim S.A. were used as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior of testosterone undecanoate soft capsules in healthy postmenopausal female subjects in China was compared to evaluate the bioequivalence of the two preparations. At the same time, the safety of the test preparation and reference preparation of testosterone undecanoate soft capsules after a single oral administration after a meal was evaluated in healthy postmenopausal female subjects.