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An open label, multicenter, balanced, randomized, parallel, two-treatment, single-period, single-dose, pharmacokinetic bioequivalence study of Luphere Depot Injection 30 mg of Daewoong Pharmaceutical Co. Ltd, South Korea with LUCRIN Depot (leuprorelin acetate for depot suspension) 30 mg of AbbVie Pty Ltd Australia in adult male subjects with metastatic prostate cancer undergoing initial therapy under fasting conditions.

Trial Profile

An open label, multicenter, balanced, randomized, parallel, two-treatment, single-period, single-dose, pharmacokinetic bioequivalence study of Luphere Depot Injection 30 mg of Daewoong Pharmaceutical Co. Ltd, South Korea with LUCRIN Depot (leuprorelin acetate for depot suspension) 30 mg of AbbVie Pty Ltd Australia in adult male subjects with metastatic prostate cancer undergoing initial therapy under fasting conditions.

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 29 Jan 2020

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At a glance

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

    • 29 Jan 2020 New trial record

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