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
Study ID
NCT07069335
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
19 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 17, 2025
Status verified
Jul 2025
Primary completion
May 15, 2026
Completion
May 15, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence 1 (TR)
    Subjects are randomized into two sequence groups (Sequence 1 and 2). In Sequence 1, subjects receive T (1d-7d) then R (8d-14d) T: Test treatment BR2022 (Olaparib 150.00mg) R: Reference treatment BR2022-1 (Olaparib 150 mg) Washout interval: None
  • Experimental: Sequence 2 (RT)
    Subjects are randomized into two sequence groups (Sequence 1 and 2). In Sequence 2, subjects receive R (1d-7d) then T (8d-14d) T: Test treatment BR2022 (Olaparib 150.00mg) R: Reference treatment BR2022-1 (Olaparib 150 mg) Washout interval: None

Primary Outcome Measure

Pharmacokinetic variable - Cmax [ Time Frame: From Day 6 to Day 7 after dose administration ]

Central Contacts

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