Type2 Diabetes MellitusPhase 1NCT07034781
A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults
A Phase 1 study testing Comparator 1, Comparator 2 and Test Drug in people with Type2 Diabetes Mellitus, run by AJU Pharm Co., Ltd. at 1 site in South Korea.
Trial summary
To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Comparator 1, Comparator 2 and Test Drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2025to Nov 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers aged 19 to 50 years at the time of screening.
- Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.
- Male subjects must weigh ≥50 kg.
- Female subjects must weigh ≥45 kg.
- No clinically significant congenital or chronic diseases requiring treatment, based on medical history and physical examination.
- Clinically acceptable results from laboratory tests (e.g., hematology, biochemistry, serology, urinalysis) and electrocardiogram (ECG) at screening, as determined by the investigator.
- Willing to use medically accepted contraception (excluding hormonal methods) from the first dose until 50 days after the last dose, and agrees not to donate sperm or eggs during this period.
- Able and willing to provide written informed consent after receiving a full explanation of the study.
Who cannot join
- Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.
- Participation in any clinical trial involving investigational products within 6 months prior to the first dose.
- Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose.
- History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).
- History of excessive alcohol consumption within 1 month prior to the first dose:
- >21 drinks/week for males, >14 drinks/week for females (1 drink = 50 mL soju, 30 mL whiskey, or 250 mL beer)
Show all 18Show fewer
- Known hypersensitivity to any component of the investigational product.
- Clinically significant renal, hepatic, cardiovascular, respiratory, metabolic, or infectious diseases, including but not limited to:
- Moderate to severe renal impairment (eGFR or creatinine clearance <45 mL/min)
- Dialysis
- Acute or unstable heart failure
- Acute myocardial infarction, septicemia, or shock
- Type 1 diabetes, metabolic acidosis, or history of diabetic ketoacidosis
- Major surgery planned during the study (except minor procedures not affecting food or fluid intake)
- Severe infections, trauma, or nutritional deficiencies
- Positive pregnancy test or currently breastfeeding (for female subjects).
- History of significant psychiatric illness.
- Determined by the investigator to be unsuitable for the study for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do
About this study
Official title: An Open-label, 2-arm, Single-sequence, Single Oral Dosing, Crossover Clinical Trial to Evaluate Safety and the Pharmacokinetics Between Dapagliflozin, Linagliptin and Metformin in Healthy Adult Subjects
To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Comparator 1, Comparator 2, Test Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator 1Drug
Dapagliflozin 10mg + Linagliptin 5mg
Comparator 2Drug
Metformin 1000mg
Test DrugDrug
Fixed-dose combination tablet (AJU-A53)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Two-period, single-dose, crossover study Receives: Drug: Comparator 1; Drug: Comparator 2; Drug: Test Drug |
| Group B | Experimental | Two-period, single-dose, crossover study (reversed order) Receives: Drug: Comparator 1; Drug: Comparator 2; Drug: Test Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Dapagliflozin
To assess the maximum observed plasma concentration (Cmax) of Dapagliflozin
Measured: 0 hour ~ 48 hour after drug administration
AUCt of Dapagliflozin
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Dapagliflozin
Measured: 0 hour ~ 48 hour after drug administration
Cmax of Linagliptin
To assess the maximum observed plasma concentration (Cmax) of Linagliptin
Measured: 0 hour ~ 72 hour after drug administration
AUCt of Linagliptin
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Linagliptin
Measured: 0 hour ~ 72 hour after drug administration
Cmax of Metformin
To assess the maximum observed plasma concentration (Cmax) of Metformin
Measured: 0 hour ~ 48 hour after drug administration
AUCt of Metformin
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Metformin
Measured: 0 hour ~ 48 hour after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study startAug 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AJU Pharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034781
- Sponsor's protocol ID
- 24-IP012
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, 2-arm, Single-sequence, Single Oral Dosing, Crossover Clinical Trial to Evaluate Safety and the Pharmacokinetics Between Dapagliflozin, Linagliptin and Metformin in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07034781
- Acronym / sponsor ID
- 24-IP012
- Conditions
- Type2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AJU Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 24 Jun 2025 (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.
To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Comparator 1, Drug: Comparator 2, Drug: Test DrugTwo-period, single-dose, crossover study |
| Group B | Experimental | Drug: Comparator 1, Drug: Comparator 2, Drug: Test DrugTwo-period, single-dose, crossover study (reversed order) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adult volunteers aged 19 to 50 years at the time of screening.
- Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.
- No clinically significant congenital or chronic diseases requiring treatment, based on medical history and physical examination.
- Clinically acceptable results from laboratory tests (e.g., hematology, biochemistry, serology, urinalysis) and electrocardiogram (ECG) at screening, as determined by the investigator.
- Willing to use medically accepted contraception (excluding hormonal methods) from the first dose until 50 days after the last dose, and agrees not to donate sperm or eggs during this period.
Key exclusion criteria (18 listed)
- Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.
- Participation in any clinical trial involving investigational products within 6 months prior to the first dose.
- Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose.
- History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).
- History of excessive alcohol consumption within 1 month prior to the first dose:
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 |
|---|---|---|
| Comparator 1Dapagliflozin 10mg + Linagliptin 5mg | Drug | Group A, Group B |
| Comparator 2Metformin 1000mg | Drug | Group A, Group B |
| Test DrugFixed-dose combination tablet (AJU-A53) | Drug | Group A, Group B |
Primary outcome
Cmax of Dapagliflozin
Time frame: 0 hour ~ 48 hour after drug administration
To assess the maximum observed plasma concentration (Cmax) of Dapagliflozin
AUCt of Dapagliflozin
Time frame: 0 hour ~ 48 hour after drug administration
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Dapagliflozin
Cmax of Linagliptin
Time frame: 0 hour ~ 72 hour after drug administration
To assess the maximum observed plasma concentration (Cmax) of Linagliptin
AUCt of Linagliptin
Time frame: 0 hour ~ 72 hour after drug administration
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Linagliptin
Cmax of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
To assess the maximum observed plasma concentration (Cmax) of Metformin
AUCt of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Metformin
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 24 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Comparator 1, Comparator 2 and Test Drug in people with Type2 Diabetes Mellitus, run by AJU Pharm Co., Ltd. at 1 site in South Korea.
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 8 inclusion and 18 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of Dapagliflozin (time frame: 0 hour ~ 48 hour after drug administration). The study lists 6 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 24 Jun 2025.