A Study to Compare the Pharmacokinetics and Safety of the ATB-U101 and ATB-U1011+ATB-U1012 and ATB-1011+ATB-1012 in Healthy Caucasian Participants

Summary

The goal of this Phase 1 clinical trial is to compare the pharmacokinetics and safety of a fixed-dose combination tablet (ATB-U101) versus co-administration of its individual components in healthy Caucasian adult volunteers. The main questions it aims to answer are: * Is the Cmax of Olmesartan and Dapagliflozin bioequivalent across the three treatment regimens? * Is the AUClast of Olmesartan and Dapagliflozin bioequivalent across the three treatment regimens? Researchers will compare ATB-U101 (fixed-dose combination, 40 mg/10 mg) against two reference co-administrations - ATB-1011+ATB-1012 (Korean-approved Olmetec + Forxiga) and ATB-U1011+ATB-U1012 (US-approved Benicar + Farxiga) - to see if the 90% confidence intervals of the geometric mean ratios for the primary PK parameters fall within the bioequivalence range of 80.00-125.00%. Participants will: * Be admitted to the clinical trial center three times (Days 1, 8, and 15), each separated by a 7-day washout period * Receive a single oral dose of one assigned treatment per period under fasting conditions (minimum 10 hours) with 240 mL of water, in a randomized crossover sequence * Have blood samples collected at up to 18 timepoints per period (up to 48 hours post-dose) for PK analysis * Undergo safety assessments including vital signs, ECG, physical examination, and laboratory tests throughout the study, with a final follow-up visit around Day 21-24

Timeline

Start

2026-05-18

Primary completion

2026-07-31

Completion

2026-08-31

Drugs

Indications