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A Bioequivalence Study to Evaluate Pharmacokinetics and Safety of BR2022 and BR2022-1 in Patients With Deleterious or Suspected Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer
Sponsor: Boryung Pharmaceutical Co., Ltd
Summary
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.
Official title: A Multi-centre, Open-Label, Randomized, Two-Stage, Two-treatment, Two-Period, Multiple-Dose, Crossover Bioequivalence Study to Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2022 and BR2022-1 in Patients With Deleterious or Suspected Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer
Key Details
Gender
FEMALE
Age Range
19 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-06-17
Completion Date
2026-05-15
Last Updated
2025-07-16
Healthy Volunteers
No
Conditions
Interventions
Olaparib 150 MG
Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
Locations (1)
Asan Medical Center
Seoul, Songpa District, South Korea