This was a multicenter, open-label, randomized, crossover bioequivalence study to evaluate the pharmacokinetics and safety of BR2022 and BR2022-1 in Patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer.
This study will be conducted in two stages. Stage 1 enrolls patients who have been taking BR2022-1 as existing therapy, and results will be evaluated before deciding whether to proceed with the Stage 2 part of the study and enroll more patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
Asan Medical Center
Seoul, Songpa District, South Korea
RECRUITINGPharmacokinetic variable - Cmax
Maximum plasma concentration of BR2022 and BR2022-1
Time frame: From Day 6 to Day 7 after dose administration
Pharmacokinetic variable - AUCtau
Area under the drug concentration-time curve over the time interval from Day 6 to Day 7 after dose administration
Time frame: From Day 6 to Day 7 after dose administration
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