A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fed)
Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg: Orally administered once per day
Dapagliflozin 10 mg: Orally administered once per day
Pioglitazone 30 mg: Orally administered once per day
Metformin HCl 1000 mg: Orally administered once per day
Study 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
Sex
ALL
Min age
19 Years
Max age
—
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
Primary outcome measure(s)
Pharmacokinetic variable - AUCt — [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration] Area under the drug concentration-time curve over the time interval of "BR3006"
Pharmacokinetic variable - Cmax — [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration] Maximum plasma concentration of "BR3006"
Trial sites (1)
Facility
City
Region
Status
H Plus Yangji Hospital
Seoul
Gwanak-gu
Recruiting
More Boryung Pharmaceutical Co., Ltd trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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