Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age19+
SponsorDaewoong Pharmaceutical Co. LTD.
About this trial
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
Eligibility criteria
Qualifiers
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 consecutive days.
Subjects who, in the judgment of the principal investigator require a stable dose of olaparib 300 mg (two 150 mg tablets) administered orally twice daily 4. Subjects with an estimated life expectancy of at least 12 weeks. 5. Subjects with a body mass index(BMI) between 18.50 and 30.00 kg/m² at screening.
Disqualifiers
Subjects with a history of hypersensitivity to the investigational product or any of its components.
Radiotherapy within 4 weeks prior to screening.
Other anticancer therapies within 4 weeks prior to screening. 4. Subjects who have undergone major surgery within 4 weeks prior to screening or who have not adequately recovered from a previous major surgery.
Trial design
Treatments tested in this trial
- DWZ2501 (Olaparib 150mg)
- DWC202510 (Olaparib 150mg)
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov