Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer
NCT07371104 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-05-08
Summary
A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients with Advanced BRCA-mutated High-grade Ovarian Cancer
Conditions
Interventions
- DRUG
-
DWZ2501 (Olaparib 150mg)
Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
- DRUG
-
DWC202510 (Olaparib 150mg)
Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
Sponsors & Collaborators
-
Daewoong Pharmaceutical Co. LTD.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-22
- Primary Completion
- 2027-03-31
- Completion
- 2027-03-31
Countries
- South Korea
Study Locations
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