A Multicentric, Open-Label, Randomized, Three-Treatment, Parallel, Single-Dose Clinical Bioequivalence Study of Subcutaneous Leuprolide Acetate 11.25 mg (Luphere Depot)-Test 1 (T1) and Leuprolide Acetate 11.25 mg (Luphere Depot) -Test 2 (T2) of Daewoong Pharmaceuticals Co. Ltd., in comparison with Leuprolide Acetate 11.25 mg (Lucrin Depot) -Reference (R) of Takeda Pharmaceutical Company Ltd., in Male Prostatic Carcinoma Subjects Undergoing Initial Therapy
Phase of Trial: Phase II
Latest Information Update: 03 Jul 2019
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At a glance
- Drugs Leuprorelin (Primary)
- Indications Carcinoma; Prostate cancer
- Focus Pharmacokinetics
- Sponsors Daewoong Pharmaceutical
- 18 Sep 2015 Status changed to completed.
- 31 Mar 2014 According to the Clinical Trials Registry - India record, status changed from not yet recruiting to recruiting.
- 19 Feb 2014 New trial record