/ Not yet recruitingNot Applicable 评估伊拉地平缓释胶囊在中国健康受试者体内的生物等效性预试验
[Translation] A pilot study to evaluate the bioequivalence of isradipine sustained-release capsules in healthy Chinese volunteers
主要研究目的:以沈阳沃森药物研究所、北京红太阳药业有限公司研制的伊拉地平缓释胶囊为受试制剂T,以Novartis New Zealand Limited生产的DynaCirc SRO®为参比制剂R,在空腹条件下,进行生物等效性预试验。 次要研究目的:评估空腹服用伊拉地平缓释胶囊在中国健康受试者中的安全性。
[Translation] Main research purpose: Isradipine sustained-release capsules developed by Shenyang Watson Pharmaceutical Research Institute and Beijing Red Sun Pharmaceutical Co., Ltd. were used as the test preparation T, and DynaCirc SRO® produced by Novartis New Zealand Limited was used as the reference preparation R. Conduct a bioequivalence preliminary test under fasting conditions. Secondary study objectives: To evaluate the safety of isradipine extended-release capsules taken on an empty stomach in healthy Chinese subjects.
/ CompletedNot Applicable [Translation] Pharmacokinetic study of leuprolide acetate injection in humans
研究醋酸亮丙瑞林注射液在健康人体内的药代动力学,探讨药物在人体内的吸收、分布、代谢和排泄的特点,阐明其药代动力学特征,为醋酸亮丙瑞林注射液的临床给药方案设计及剂量确定提供确切的实验依据,为Ⅱ期临床试验的给药方案提供理论依据。
[Translation] To study the pharmacokinetics of leuprolide acetate injection in healthy humans, explore the characteristics of drug absorption, distribution, metabolism and excretion in the human body, and clarify its pharmacokinetic characteristics, so as to provide a definite experimental basis for the design of clinical dosing regimen and dosage determination of leuprolide acetate injection, and provide a theoretical basis for the dosing regimen of Phase II clinical trials.
评价国产注射用醋酸亮丙瑞林即释制剂的安全性和有效性的随机、开放、阳性药对照的Ⅱ期临床试验
[Translation] A randomized, open-label, active-controlled phase II clinical trial to evaluate the safety and efficacy of a domestically produced immediate-release leuprolide acetate injection
评价国产注射用醋酸亮丙瑞林即释制剂与注射用醋酸亮丙瑞林缓释制剂治疗前列腺癌的有效性和安全性。
[Translation] To evaluate the efficacy and safety of domestic leuprolide acetate immediate-release injection and leuprolide acetate sustained-release injection in the treatment of prostate cancer.
100 Clinical Results associated with Shenyang Wosen Institute of Pharmacy
0 Patents (Medical) associated with Shenyang Wosen Institute of Pharmacy
100 Deals associated with Shenyang Wosen Institute of Pharmacy
100 Translational Medicine associated with Shenyang Wosen Institute of Pharmacy