Diabetes Mellitus, Type 2Phase 1NCT04972539
Evaluation of Pharmacokinetics and Safety of AJU-A51 in Healthy Adults
A Phase 1 study testing AJU-A51 Tab. and A51R1 Tab. and A51R2 Tab. in people with Diabetes Mellitus, Type 2, run by AJU Pharm Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate the safety and pharmacokinetic characteristics of AJU-A51 in healthy adults Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- AJU-A51 Tab. and A51R1 Tab. and A51R2 Tab.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2020to 9 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults over the age of 19 years at the time of screening
- Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) < 29.9 kg/m2 and total body weight ≥ 50 kg
- BMI = Weight(kg)/ Height(m)2
- Individuals who were deemed to be appropriate as study subjects screening examination(laboratory tests and ECG etc.)
- Individuals who agreed proper contraception during the study
- Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation
Who cannot join
- Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
- Individuals with an active chronic or acute disease within 1 month.
- Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
- Individuals with a severe allergies(except for allergic rhinitis or dermatitis)
- Individuals with the following medical histories at screening test:
- T1DM or diabetic ketoacidosis
Show all 12Show fewer
- Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- Renal disorder or pancreatitis etc.
- A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from 48hr prior to the first
- Individuals who cannot eat standard meal in institution
- Women who are pregnant or may be pregnant
- Individuals who were deemed to be inappropriate to participate in the study by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open, Single-dose, 2x2 Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of A51R1 and A51R2 or Administration of AJU-A51 in Healthy Volunteers Under Fasting Conditions
To evaluate the safety and pharmacokinetic characteristics of AJU-A51 in healthy adults
Read the detailed description
This study is to assess the safety and pharmacokinetic characteristics between co-administration of A51R1 with A51R2 and administration of AJU-A51.
This is an open-label, randomized, single-dose, 2x2 crossover study in healthy male and female subjects to assess the bioequivalence after taking the study drugs.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- AJU-A51 Tab., A51R1 Tab. and A51R2 Tab.
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AJU-A51 Tab.Drug
Also called Test drug
Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet
A51R1 Tab. and A51R2 Tab.Drug
Also called Reference drug
Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose Period 2: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose Receives: Drug: AJU-A51 Tab.; Drug: A51R1 Tab. and A51R2 Tab. |
| Sequence B | Experimental | Period 1: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose Period 2: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose Receives: Drug: AJU-A51 Tab.; Drug: A51R1 Tab. and A51R2 Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt(Area Under Curve last) of AJU-A51
Area under the plasma concentration time curve of AJU-A51
Measured: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
Cmax
The maximum concentration observed of AJU-A51 over blood sampling time.
Measured: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Aug 2020
- Primary completion30 Nov 2020
- Study completion9 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, 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
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AJU Pharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jang Hee Hong, Principal investigator, Chungnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972539
- Sponsor's protocol ID
- 20DM10202
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Single-dose, 2x2 Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of A51R1 and A51R2 or Administration of AJU-A51 in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT04972539
- Acronym / sponsor ID
- 20DM10202
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AJU Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 22 Jul 2021 (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 pharmacokinetic characteristics of AJU-A51 in healthy adults
Detailed description
This study is to assess the safety and pharmacokinetic characteristics between co-administration of A51R1 with A51R2 and administration of AJU-A51.
This is an open-label, randomized, single-dose, 2x2 crossover study in healthy male and female subjects to assess the bioequivalence after taking the study drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: AJU-A51 Tab., Drug: A51R1 Tab. and A51R2 Tab.Period 1: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose Period 2: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose |
| Sequence B | Experimental | Drug: AJU-A51 Tab., Drug: A51R1 Tab. and A51R2 Tab.Period 1: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose Period 2: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adults over the age of 19 years at the time of screening
- Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) < 29.9 kg/m2 and total body weight ≥ 50 kg
- Individuals who were deemed to be appropriate as study subjects screening examination(laboratory tests and ECG etc.)
- Individuals who agreed proper contraception during the study
- Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation
Key exclusion criteria (12 listed)
- Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
- Individuals with an active chronic or acute disease within 1 month.
- Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
- Individuals with a severe allergies(except for allergic rhinitis or dermatitis)
- Individuals with the following medical histories at screening test:
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 |
|---|---|---|
| AJU-A51 Tab.Also: Test drugSingle oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet | Drug | Sequence A, Sequence B |
| A51R1 Tab. and A51R2 Tab.Also: Reference drugSingle oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together | Drug | Sequence A, Sequence B |
Primary outcome
AUCt(Area Under Curve last) of AJU-A51
Time frame: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
Area under the plasma concentration time curve of AJU-A51
Cmax
Time frame: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
The maximum concentration observed of AJU-A51 over blood sampling time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
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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. This study is not recruiting at the moment.
Jang Hee Hong principal investigator
Chungnam National University
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 AJU-A51 Tab. and A51R1 Tab. and A51R2 Tab. in people with Diabetes Mellitus, Type 2, 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 22 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUCt(Area Under Curve last) of AJU-A51 (time frame: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose). The study lists 2 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 22 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.