NCT07083401 A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fed)
| NCT ID | NCT07083401 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Boryung Pharmaceutical Co., Ltd |
| Condition | Diabete Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-07-05 |
| Primary Completion | 2026-07-05 |
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 40 participants in total. It began in 2025-07-05 with a primary completion date of 2026-07-05.
⚠ 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
This was an open-label, randomized, fed, single-dose, 2-sequence, 2- period crossover study to evaluate the pharmacokinetics and safety between single oral administration of "BR3006" and co-administration of "BR3006A", "BR3006B," and "BR3006C" in healthy adult volunteers.
Eligibility Criteria
Inclusion Criteria: * Adults aged over 19 at the time of consent * Those who are eligible to participate in the clinical trial at the discretion of the principal investigator (or a subinvestigator) through laboratory tests such as hematology tests, blood chemistry tests, serology tests, urine tests, and electrocardiogram (ECG) tests that were planned/performed with specification to the investigational product. * Those who provided written consent after receiving sufficient explanations and fully understood the objective and details of this clinical trial, the characteristics of the investigational product, and the expected adverse events. Exclusion Criteria: * Those who have administered investigational products within 6 months from the first dose administration date in another clinical trial (including bioequivalent studies) (The end of study date is based on the last dose administration date.) * Those who have undergone gastrointestinal surgeries or have gastrointestinal diseases (except appendectomy or hernia surgery) that may affect the absorption of the investigational products * Female subjects who are pregnant, suspected of pregnancy, or nursing
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07083401 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Diabete Mellitus. 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 NCT07083401 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 NCT07083401 currently recruiting?
Yes, NCT07083401 is actively recruiting participants. Contact the research team at syoh@boryung.co.kr for enrollment information.
Where is the NCT07083401 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07083401 clinical trial?
NCT07083401 is sponsored by Boryung Pharmaceutical Co., Ltd. The trial plans to enroll 40 participants.