This was an open-label, randomized, fasting, 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.
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.
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
Those who are pregnant, suspected of pregnancy, or nursing
Crossover
Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg
DrugOrally administered once per day
Dapagliflozin 10 mg
DrugOrally administered once per day
Pioglitazone 30 mg
DrugOrally administered once per day
Metformin HCl 1000 mg
DrugOrally administered once per day
Pharmacokinetic variable - Cmax
Maximum plasma concentration of "BR3006" and "BR3006A," "BR3006B," and "BR3006C"
Pharmacokinetic variable - AUCt
Area under the drug concentration-time curve over the time interval of "BR3006" and "BR3006A," "BR3006B," and "BR3006C"
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