NCT06867497 A Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2021 and BR2021-1
| NCT ID | NCT06867497 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Boryung Pharmaceutical Co., Ltd |
| Condition | Metastatic Adenocarcinoma of the Pancreas |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-02-24 |
| Primary Completion | 2025-10-28 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this clinical study is to compare and evaluate the pharmacokinetic characteristics and the safety between administration of BR2021 and BR2021-1 in patients with metastatic adenocarcinoma of the pancreas
Eligibility Criteria
Inclusion Criteria: * Those with histologically or cytologically proven metastatic adenocarcinoma of the pancreas * Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using medically recognized methods of contraception (contraceptives administration \& transplantation or intrauterine device(IUD), sterilization(vasectomy, tubal ligation, etc.), barrier methods (spermicide \& male condom, combined use of contraceptive diaphragm, sponge or cervical cap)) from the date of the first administration of the investigational products to at least 6 months after the last administration date and disagree to provide their sperm or ovum. * Those who spontaneously decide to participate and sign written consent to comply with the subject's precautions after listening to and fully understanding detailed explanation of this clinical trial Exclusion Criteria: * In the case of a female subject, pregnant woman or those suspected pregnancy or lactating wo