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观察DX01单剂量、多剂量给药后在健康女性受试者体内的血药浓度经时过程。
[Translation] To observe the time course of DX01 plasma concentration in healthy female subjects after single-dose and multiple-dose administration.
采用单中心、开放、平行、无对照、单周期的单剂量、多剂量阴道给药的试验方法,观察DX01给药后在健康女性受试者体内的血药浓度经时过程。评价DX01在中国人体内的吸收,分布,代谢,排泄的药代动力学过程,为DX01的药品注册和生产上市提供临床依据。
[Translation] A single-center, open, parallel, uncontrolled, single-cycle, single-dose and multiple-dose vaginal administration test method was used to observe the time course of blood drug concentration of DX01 in healthy female subjects after administration. The pharmacokinetic process of absorption, distribution, metabolism and excretion of DX01 in Chinese people was evaluated to provide clinical basis for the drug registration and production and marketing of DX01.
DX01治疗滴虫阴道炎和细菌性阴道病的多中心、随机、盲法、阳性药物平行对照Ⅲ期临床试验
[Translation] A multicenter, randomized, blinded, active drug parallel controlled phase III clinical trial of DX01 for the treatment of Trichomonas vaginitis and bacterial vaginosis
以甲硝唑栓为对照评价DX01治疗滴虫阴道炎、细菌性阴道病的有效性和安全性的多中心、随机、盲法、阳性药物平行对照临床试验
[Translation] A multicenter, randomized, blinded, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of DX01 in the treatment of Trichomonas vaginitis and bacterial vaginosis using metronidazole suppositories as a control
100 Clinical Results associated with Fuzhou Hanli Biomedical Technology Co., Ltd.
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