A Phase 1 Study to Compare Safety and Drug Levels of Single Oral Dose BR3006 Versus Separate Dapagliflozin, Pioglitazone, and Metformin Tablets 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)