RecruitingPhase 1NCT07069335

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

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


Sponsor

Boryung Pharmaceutical Co., Ltd

Enrollment

24 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 19 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study is checking whether two formulations of a PARP inhibitor drug (olaparib) — BR2022 and BR2022-1 — are absorbed and processed by the body in the same way (called bioequivalence), in women with advanced ovarian cancer linked to a BRCA gene mutation who are already being treated with stable-dose olaparib. **You may be eligible if...** - You are a female aged 19 to 74 - You have advanced ovarian, fallopian tube, or primary peritoneal cancer with a BRCA gene mutation (inherited or acquired) - You have already been taking olaparib at a stable dose for more than 3 months **You may NOT be eligible if...** - You have a history of severe allergic reactions to similar drugs - You have gastrointestinal conditions (such as Crohn's disease, reflux disease, or stomach ulcers) or prior GI surgery that could affect drug absorption - You are pregnant, possibly pregnant, or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOlaparib 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07069335


Related Trials