Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period Crossover Study Comparing "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adults

What this Trial Is About

Researchers are evaluating the pharmacokinetics and safety of a single oral dose of "BR3006" compared to the co-administration of "BR3006A", "BR3006B", and "BR3006C" in healthy adult volunteers. The study is an open-label, randomized, fed, single-dose, 2-sequence, 2-period crossover trial involving 40 healthy participants. It focuses on understanding how these drug forms behave in the body and their safety profiles when taken with food. The study involves two treatment sequences. In one sequence, participants receive the combination tablet "BR3006" containing dapagliflozin 10 mg, pioglitazone 30 mg, and metformin HCl 1000 mg. In the other sequence, they receive the three drugs separately as "BR3006A", "BR3006B", and "BR3006C" with the same dosages. Each participant will receive both treatments in different periods according to the randomized sequence. During the study, participants will undergo laboratory tests including hematology, blood chemistry, serology, urine tests, and electrocardiograms to monitor safety and drug effects. Pharmacokinetic variables such as the area under the curve (AUCt) and peak drug concentration (Cmax) will be measured from pre-dose to three days post-dose. Participant safety and drug absorption will be closely observed throughout the trial, which is expected to complete by July 2026.

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