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

Trial Profile

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

Completed
Phase of Trial: Phase II

Latest Information Update: 01 Sep 2016

At a glance

  • Drugs Leuprorelin (Primary)
  • Indications Prostate cancer
  • Focus Pharmacokinetics
  • Sponsors Daewoong Pharmaceutical
  • Most Recent Events

    • 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
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top