NCT07069335

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: Female
• Age: 19 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Olaparib 150 MG	Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration

Timeline

• Start date: 2025-06-17
• Primary completion: 2026-05-15
• Completion: 2026-05-15
• First posted: 2025-07-16
• Last updated: 2025-07-16

Locations

1 site across 1 country: South Korea