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โ† Trials
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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

RecruitingPhase 1Ages 19 Years - 74 YearsFemaleBoryung Pharmaceutical Co., Ltd
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Females aged 19 -74 at the time of consent 2. Those who voluntarily signed the informed consent to participate in this study 3. 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. Exclusion Criteria: 1. 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 2. 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 3. Those who are pregnant, suspected of pregnancy, or nursing
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What it tests

  • Olaparib 150 MG
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Where

1 site
Asan Medical Center
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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