/ 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.
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