Phase 1 Study to Evaluate the Pharmacokinetics and Safety Following SC Administration of DWJ108J in Patients With Prostate Cancer
NCT03029533 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2017-01-24
Summary
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety of DWJ108J (leuprolide acetate) and Leuplin DPS Inj administered subcutaneously in patients with prostate cancer
Conditions
Interventions
- DRUG
-
Leuprolide Acetate
DWJ108J, SC injection, once(Day1)
- DRUG
-
Leuprolide Acetate
Leuplin DPS Inj, SC injection, once(Day1)
Sponsors & Collaborators
-
Daewoong Pharmaceutical Co. LTD.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-28
- Primary Completion
- 2017-11-30
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