Cisen Pharmaceutical Ltd.

This study is a multicenter, randomized, double-blind, active-controlled, dose-ranging clinical trial designed to evaluate the efficacy and safety of the investigational drug compared to the active comparator in the treatment of vulvovaginal candidiasis. The trial consists of three phases: screening/enrollment (D-3 to D-1), treatment period (D1 to D3), and follow-up period (D4, D11±2, D25±3). Eligible subjects in this study will be randomized in a 1:1:1:1 ratio to three investigational drug arms with different dosing regimens and one active control arm. Specifically, Group A will receive WXSH0102 tablets with 1400 mg on the first day followed by a maintenance dose of 700 mg for two consecutive days, Group B will receive WXSH0102 tablets with 1000 mg on the first day followed by a maintenance dose of 500 mg for two consecutive days, Group C will receive WXSH0102 tablets with 600 mg on the first day followed by a maintenance dose of 300 mg for two consecutive days, and Group D (active control group) will receive fluconazole capsules for only one day on D1. All medications will be administered orally.

主要研究目的：按有关生物等效性试验的规定，选择興和株式会社为持证商的佩玛贝特片（商品名：PARMODIA，规格：0.1mg）为参比制剂，对辰欣药业股份有限公司生产并提供的受试制剂佩玛贝特片（规格：0.1mg）进行空腹给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹给药条件下的生物等效性。 次要研究目的：观察健康志愿受试者口服受试制剂佩玛贝特片（规格：0.1mg）和参比制剂佩玛贝特片（商品名：PARMODIA，规格：0.1mg）的安全性。

主要研究目的：按有关生物等效性试验的规定，选择Laboratoires Juvise Pharmaceuticals为持证商的氢氯噻嗪片（商品名：ESIDREX，规格：25mg）为参比制剂，对辰欣药业股份有限公司生产并提供的受试制剂氢氯噻嗪片（规格：25mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。 次要研究目的：观察健康志愿受试者口服受试制剂氢氯噻嗪片（规格：25mg）和参比制剂氢氯噻嗪片（商品名：ESIDREX，规格：25mg）的安全性。