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

Sponsor
Daewoong Pharmaceutical Co. LTD.
Study ID
NCT07371104
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Apr 22, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence A (Olaparib, RT)
    Subjects are randomized into two sequence groups. In Sequence A, subjects receive R then T. T: DWZ2501(Olaparib) R: DW202510(Olaparib)
  • Experimental: Sequence B (Olaparib, TR)
    Subjects are randomized into two sequence groups. In Sequence B, subjects receive T then R. T: DWZ2501(Olaparib) R: DW202510(Olaparib)

Primary Outcome Measure

Cmax [ Time Frame: Day 8, Day 16 after dose administration ]

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