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.
Females aged 19 -74 at the time of consent
Those who voluntarily signed the informed consent to participate in this study
Patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been taking stable doses of olaparib for more than 3 months before screening.
Those who have a history of severe hypersensitivity to drugs that include the ingredients of the investigational product or have a history of clinically significant hypersensitivity reactions
Those who have gastrointestinal disorders (e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or have had surgeries (excluding appendectomy or hernia surgery) that may affect the absorption of the investigational products
Those who are pregnant, suspected of pregnancy, or nursing
Crossover
Olaparib 150 MG
DrugSubjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
Pharmacokinetic variable - Cmax
Maximum plasma concentration of BR2022 and BR2022-1
Pharmacokinetic variable - AUCtau
Area under the drug concentration-time curve over the time interval from Day 6 to Day 7 after dose administration
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