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

NCT07590466 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: ATB-U101-001
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Diabete Type 2; Hypertension

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

ATB-U101

EXPERIMENTAL

Drug: ATB-U101

ATB-1011 and ATB-1012

EXPERIMENTAL

Drug: ATB-1011; Drug: ATB-1012

ATB-U1011 and ATB-U1012

EXPERIMENTAL

Drug: ATB-U1011; Drug: ATB-U1012

Interventions

ATB-U101 DRUG

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.

ATB-U101

ATB-1011 DRUG

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.

ATB-1011 and ATB-1012

ATB-U1011 DRUG

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.

ATB-U1011 and ATB-U1012

ATB-1012 DRUG

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.

ATB-1011 and ATB-1012

ATB-U1012 DRUG

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.

ATB-U1011 and ATB-U1012

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Autotelicbio: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Eunji Byeon

CONTACT

82-70-4484-5587; ejb@autotelic.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 15, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05