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A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fed)
RECRUITINGPhase 1Sponsored by Boryung Pharmaceutical Co., Ltd
Actively Recruiting
PhasePhase 1
SponsorBoryung Pharmaceutical Co., Ltd
Started2025-07-05
Est. completion2026-07-05
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07083401
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
Age: 19 Years+Healthy volunteers accepted
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
Conditions2
Diabete MellitusDiabetes
Interventions4
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Actively Recruiting
PhasePhase 1
SponsorBoryung Pharmaceutical Co., Ltd
Started2025-07-05
Est. completion2026-07-05
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07083401