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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age19-74
SponsorBoryung Pharmaceutical Co., Ltd

About this trial

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 criteria

Qualifiers

Females aged 19 -74 at the time of consent

Those who voluntarily signed the informed consent to participate in this study

Patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been taking stable doses of olaparib for more than 3 months before screening.

Disqualifiers

Those who have a history of severe hypersensitivity to drugs that include the ingredients of the investigational product or have a history of clinically significant hypersensitivity reactions

Those who have gastrointestinal disorders (e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or have had surgeries (excluding appendectomy or hernia surgery) that may affect the absorption of the investigational products

Those who are pregnant, suspected of pregnancy, or nursing

Trial design

Treatments tested in this trial

  • Olaparib 150 MG

Treatment groups

24 Participants
are divided into 2 treatment groups