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RECRUITING
NCT07069335
PHASE1

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

View on ClinicalTrials.gov

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

DRUG

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