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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
DWZ2501 (Olaparib 150mg)
DrugSubjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
DWC202510 (Olaparib 150mg)
DrugSubjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Sequence A (Olaparib, RT)Experimental treatment 2 interventions
Group B: Sequence B (Olaparib, TR)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Cmax
Maximum plasma concentration of olaparib
Time frame
Day 8, Day 16 after dose administration2
AUCtau
Area under the drug concentration-time curve of olapairb
Time frame
Day 8, Day 16 after dose administrationSponsors and contacts
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Source ClinicalTrials.gov