Diabete Type 2Phase 1NCT07590466
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 study testing ATB-U101, ATB-1011 and ATB-U1011 in people with Diabete Type 2 and Hypertension, run by Autotelicbio.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 2, Hypertension
- What is being tested?
- ATB-U101, ATB-1011 and ATB-U1011
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2026to 31 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
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
- Being tested
- ATB-U101, ATB-1011, ATB-U1011, ATB-1012, ATB-U1012
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATB-U101Drug
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-1011Drug
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-U1011Drug
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-1012Drug
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-U1012Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| ATB-U101 | Experimental | Not described Receives: Drug: ATB-U101 |
| ATB-1011 and ATB-1012 | Experimental | Not described Receives: Drug: ATB-1011; Drug: ATB-1012 |
| ATB-U1011 and ATB-U1012 | Experimental | Not described Receives: Drug: ATB-U1011; Drug: ATB-U1012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Olmesartan
Measured: Pre-dose (0h) through 48 hours post-dose
AUClast of Olmesartan
Measured: Pre-dose (0h) through 48 hours post-dose
Cmax of Dapagliflozin
Measured: Pre-dose (0h) through 48 hours post-dose
AUClast of Dapagliflzin
Measured: Pre-dose (0h) through 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start18 May 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Autotelicbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590466
- Sponsor's protocol ID
- ATB-U101-001
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07590466
- Acronym / sponsor ID
- ATB-U101-001
- Conditions
- Diabete Type 2, Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- AutotelicbioIndustry (pharma, biotech, devices)
- Study start
- 18 May 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATB-U101ATB-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. | Drug | ATB-U101 |
| ATB-1011ATB-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-1011 and ATB-1012 |
| ATB-U1011ATB-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-U1011 and ATB-U1012 |
| ATB-1012ATB-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-1011 and ATB-1012 |
| ATB-U1012ATB-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-U1011 and ATB-U1012 |
Primary outcome
Cmax of Olmesartan
Time frame: Pre-dose (0h) through 48 hours post-dose
AUClast of Olmesartan
Time frame: Pre-dose (0h) through 48 hours post-dose
Cmax of Dapagliflozin
Time frame: Pre-dose (0h) through 48 hours post-dose
AUClast of Dapagliflzin
Time frame: Pre-dose (0h) through 48 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATB-U101, ATB-1011 and ATB-U1011 in people with Diabete Type 2 and Hypertension, run by Autotelicbio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eunji Byeon (82-70-4484-5587, ejb@autotelic.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of Olmesartan (time frame: Pre-dose (0h) through 48 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.