|
|
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date09 Apr 1985 |
/ Not yet recruitingPhase 1 [Translation] Study on the bioequivalence of leuprolide acetate suspension for injection in healthy volunteers
主要目的:本试验旨在研究前列腺癌患者单次皮下注射由苏州善湾生物医药科技有限公司研制、生产的注射用醋酸亮丙瑞林混悬液(7.5 mg)的药代动力学特征;以Tolmar Inc.生产的注射用醋酸亮丙瑞林混悬液(ELIGARD®,7.5 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC7-t和AUC0-t,评价两制剂生物等效性。
次要目的:评估受试制剂和参比制剂在前列腺癌患者中的安全性。
[Translation] Primary objective: This study aims to study the pharmacokinetic characteristics of a single subcutaneous injection of leuprolide acetate suspension for injection (7.5 mg) developed and produced by Suzhou Shanwan Biopharmaceutical Technology Co., Ltd. in patients with prostate cancer; using leuprolide acetate suspension for injection (ELIGARD®, 7.5 mg) produced by Tolmar Inc. as the reference preparation, compare the pharmacokinetic parameters Cmax, AUC7-t and AUC0-t of the two preparations, and evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test preparation and the reference preparation in patients with prostate cancer.
100 Clinical Results associated with Suzhou Shanwan Biopharmaceutical Technology Co. Ltd.
0 Patents (Medical) associated with Suzhou Shanwan Biopharmaceutical Technology Co. Ltd.
100 Deals associated with Suzhou Shanwan Biopharmaceutical Technology Co. Ltd.
100 Translational Medicine associated with Suzhou Shanwan Biopharmaceutical Technology Co. Ltd.