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NCT07371104
Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer
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
Trial Details
NCT ID NCT07371104
Phase PHASE1
Sponsor Daewoong Pharmaceutical Co. LTD.
Status RECRUITING
Cancer Type Ovarian Cancer
Interventions DWZ2501 (Olaparib 150mg) DWC202510 (Olaparib 150mg)
Locations (sample) Seoul, Jongno-gu, South Korea|37.566,126.9784
Key Eligibility Criteria
1\. Female subjects aged 19 years or older at the time of obtaining written informed consent. 2\. Patients with advanced high-grade ovarian cancer harboring a BRCA mutation. 3. Subjects who meet at least one of the following criteria: Subjects who have been maintained on an olaparib dosing regimen of 300 mg (two 150 mg tablets) administered orally twice daily for at least 10 cons… Subjects who, in the judgment of the principal investigator require a stable dose of olaparib 300 mg (two 150 mg tablets) administered orally twice…
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