Study of Pharmacokinetics and Safety Comparing Combined Tablet BR3006 With Separate Pills BR3006A, BR3006B, and BR3006C in Healthy Adults Fasting

What this Trial Is About

Researchers are evaluating the pharmacokinetics and safety of a single oral dose of the study drug BR3006 compared to the co-administration of its components BR3006A, BR3006B, and BR3006C in healthy adult volunteers. This open-label, randomized, fasting, single-dose, 2-sequence, 2-period crossover study aims to understand how the combined tablet and individual components behave in the body and their safety profiles. The study involves healthy adults aged 19 and older who volunteer for this evaluation. Participants will receive either a single combination tablet containing dapagliflozin 10 mg, pioglitazone 30 mg, and metformin HCl 1000 mg BR3006, or the three drugs given separately but together BR3006A, BR3006B, and BR3006C. The study uses a crossover design where volunteers receive both treatments in two different sequences, separated by a period, while fasting. The drugs are all given orally once per day during the dosing periods. During the study, participants will be closely monitored with laboratory tests including hematology, blood chemistry, serology, urine tests, and electrocardiograms to assess safety and drug behavior over time. The primary outcomes focus on measuring the maximum concentration Cmax and total exposure over time AUCt of the drugs from pre-dose through five days after administration. The study will last through the dosing and observation periods to ensure thorough evaluation of pharmacokinetics and safety.

A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fasting)