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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Diabete Type 2
• Intervention / Treatment: Drug: ATB-U101; Drug: ATB-1011; Drug: ATB-1012; Drug: ATB-U1011; Drug: ATB-U1012

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Eunji Byeon; Phone Number: 82-70-4484-5587; Email: ejb@autotelic.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATB-U101	Drug: ATB-U101; ATB-U101 is a fixed-dose combination tablet containing Olmesartan medoxomil 40 mg and Dapagliflozin 10 mg. A single oral dose will be administered under fasting conditions (minimum 10 hours) with 240 mL of water.
Experimental: ATB-1011 and ATB-1012	Drug: ATB-1011; ATB-1011 (Olmetec, Olmesartan medoxomil 40 mg) and ATB-1012 (Forxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10 hours) with 240 mL of water.; Drug: ATB-1012; ATB-1011 (Olmetec, Olmesartan medoxomil 40 mg) and ATB-1012 (Forxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10 hours) with 240 mL of water.
Experimental: ATB-U1011 and ATB-U1012	Drug: ATB-U1011; ATB-U1011 (Benicar, Olmesartan medoxomil 40 mg) and ATB-U1012 (Farxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10 hours) with 240 mL of water.; Drug: ATB-U1012; ATB-U1011 (Benicar, Olmesartan medoxomil 40 mg) and ATB-U1012 (Farxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10 hours) with 240 mL of water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of Olmesartan	Pre-dose (0h) through 48 hours post-dose
AUClast of Olmesartan	Pre-dose (0h) through 48 hours post-dose
Cmax of Dapagliflozin	Pre-dose (0h) through 48 hours post-dose
AUClast of Dapagliflzin	Pre-dose (0h) through 48 hours post-dose

Collaborators and Investigators

• Sponsor: Autotelicbio

Study record dates

Study Major Dates

• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ATB-U101-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes