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Mechanismfungal CYP51A1 inhibitors |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date21 Dec 1995 |
评价不同剂量硝酸布托康唑栓治疗外阴阴道假丝酵母菌病的疗效及安全性Ⅱa期临床研究方案
[Translation] Evaluating the efficacy and safety of different doses of butoconazole nitrate suppository in the treatment of vulvovaginal candidiasis Phase Ⅱa clinical study plan
评价不同剂量硝酸布托康唑栓治疗外阴阴道假丝酵母菌病的临床疗效及安全性,为进一步临床验证试验提供科学剂量参考。
[Translation] To evaluate the clinical efficacy and safety of different doses of butoconazole nitrate suppository in the treatment of vulvovaginal candidiasis, and to provide scientific dose reference for further clinical validation trials.
硝酸布托康唑栓Ⅰ期临床耐受性及药代动力学试验研究方案
[Translation] Phase I clinical tolerability and pharmacokinetics study protocol of butoconazole nitrate suppository
在中国女性健康受试者中进行阴道给药硝酸布托康唑栓的耐受性和临床药代动力学试验,以了解本品在人体阴道给药后的耐受性以及吸收、分布与消除的规律,为Ⅱ期临床制订合理的给药方案提供依据。
[Translation] Tolerance and clinical pharmacokinetics test of vaginal administration of butorconazole nitrate suppository in Chinese female healthy subjects to understand the tolerance, absorption, distribution and elimination of this product after vaginal administration in humans , to provide a basis for the formulation of a reasonable dosing regimen for phase II clinical trials.
100 Clinical Results associated with Jinan Haitai Medical Technology Co Ltd
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100 Translational Medicine associated with Jinan Haitai Medical Technology Co Ltd