Actively Recruiting
A Multi-centre, Open-Label, Randomized, Two-Stage, Two-Treatment, Two-Period, Multiple-Dose, Crossover Bioequivalence Study to Evaluate Pharmacokinetics and Safety of BR2022 and BR2022-1 in Patients With Germline BRCA-Mutated Advanced Ovarian Cancer
Led by Boryung Pharmaceutical Co., Ltd · Updated on 2025-07-16
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics and safety of two formulations, BR2022 and BR2022-1, in females with advanced ovarian cancer who have deleterious or suspected deleterious germline BRCA mutations. This Phase 1, multicenter, open-label, randomized, crossover bioequivalence study aims to compare these treatments in patients already on olaparib therapy, focusing on their drug absorption and safety profiles. The study is conducted in two stages. Stage 1 enrolls patients currently taking BR2022-1 as therapy, with results reviewed before proceeding to Stage 2. Participants are randomized into two groups: one receives the test treatment BR2022 (150 mg olaparib) for 7 days followed by the reference treatment BR2022-1 for 7 days, and the other group receives the treatments in reverse order. There is no washout period between treatments. Participants will be monitored through blood tests measuring pharmacokinetic variables such as peak drug concentration and overall drug exposure from days 6 to 7 after dosing. Safety assessments will be conducted throughout. The total participation lasts for about two weeks, with careful observation of drug effects and safety in this crossover design. The study is led by Boryung Pharmaceutical Co., Ltd.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 19 to 74 years at the time of consent
- Voluntarily signed informed consent to participate in the study
- Diagnosed with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Have been taking stable doses of olaparib for more than 3 months before screening
You will not qualify if you...
- History of severe hypersensitivity to drugs containing ingredients of the investigational product or clinically significant hypersensitivity reactions
- Gastrointestinal disorders or surgeries (excluding appendectomy or hernia surgery) that may affect absorption of the investigational products
- Pregnant, suspected of pregnancy, or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 14 days
Participants receive two sequences of study drugs: one week of the test treatment BR2022 (Olaparib 150 mg) followed by one week of the reference treatment BR2022-1 (Olaparib 150 mg), or vice versa, with no washout period.
2 treatment periods of 7 days each with daily dosing
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, Songpa District, South Korea, 05505
Actively Recruiting
Research Team
S
Shinyoung Oh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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