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

A Phase 1, Open-Label, Randomized, Crossover, Single-dose 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

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

Inclusion Criteria:

• Healthy Caucasian adult volunteers aged between 19 and 64 years (inclusive) at the time of screening
• Caucasian volunteers: Individuals whose parents and grandparents are European, North American, or Middle Eastern, who were born in Europe, North America, or Western Asia, and whose cumulative residence in countries outside those regions since birth is less than 10 years
• Individuals whose weight at screening is between 50.0 kg and 97.0 kg and whose body mass index (BMI) is between 18.0 kg/m2 and 30.0 kg/m2

Exclusion Criteria:

• Subjects with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• Subjects who test positive on serologic tests (hepatitis B, hepatitis C, human immunodeficiency virus [HIV], or syphilis)