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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
/ Active, not recruitingNot Applicable 研究盐酸伊伐布雷定片在中国健康志愿者中的单次及连续多次给药的药代动力学特征
[Translation] To investigate the pharmacokinetic characteristics of single and multiple doses of ivabradine hydrochloride tablets in Chinese healthy volunteers
研究亚宝药业集团股份有限公司生产的盐酸伊伐布雷定片在中国健康志愿者中的单次及连续多次给药药动学特征;为盐酸伊伐布雷定片的临床合理的给药方法提供依据。
[Translation] To study the pharmacokinetic characteristics of single and multiple doses of ivabradine hydrochloride tablets produced by Yabao Pharmaceutical Group Co., Ltd. in Chinese healthy volunteers; to provide a basis for the clinical rational administration method of ivabradine hydrochloride tablets.
100 Clinical Results associated with Changsha Dadi Medicine Research Institute
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100 Deals associated with Changsha Dadi Medicine Research Institute
100 Translational Medicine associated with Changsha Dadi Medicine Research Institute