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RECRUITING
NCT07371104
PHASE1

Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer

Sponsor: Daewoong Pharmaceutical Co. LTD.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

FEMALE

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-02-20

Completion Date

2027-03

Last Updated

2026-03-05

Healthy Volunteers

No

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

Locations (1)

Institutional Review Board of Seoul National University Hospital

Seoul, Jongno-gu, South Korea