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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-02-24 with a primary completion date of 2025-10-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 woman. * Those who have to administer this study's contraindicated drugs with the investigational product from 2 weeks before the participation until end of this study * Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug from 48 hours before the first administration date to post study visit(PSV) * Those who can't discontinue other drugs except the investigational product of this study that may affect the metabolism and excretion of the drug for the entire study period (However, if necessary, such as treatment of adverse event, it can be administrated according to investigator's judgment) * Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 4 weeks before the first administration date (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products) or those whose last administration date of their investigational products of other clinical trials doesn't elapse five times the half-life of their investigational products based on the first administration date of investigational product of this study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06867497 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 74 Years, studying Metastatic Adenocarcinoma of the Pancreas. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06867497 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06867497 currently recruiting?
Yes, NCT06867497 is actively recruiting participants. Contact the research team at syoh@boryung.co.kr for enrollment information.
Where is the NCT06867497 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06867497 clinical trial?
NCT06867497 is sponsored by Boryung Pharmaceutical Co., Ltd. The trial plans to enroll 20 participants.