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T2DM (Type 2 Diabetes Mellitus)Phase 1NCT04970940

The Drug-drug Interaction Study of AJU-A51R1 and AJU-A51R2

A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with T2DM (Type 2 Diabetes Mellitus), run by AJU Pharm Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate a pharmacokinetic drug interaction between AJU-A51R1 and AJU-A51R2 in healthy male volunteers. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
T2DM (Type 2 Diabetes Mellitus)
What is being tested?
Treatment A, Treatment B and Treatment C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
2 Jul 2020to 31 Dec 2020
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

  • Individuals whose age is over 19 and under 65 years old when visiting for initial screening test.
  • Body mass index(BMI) between 17.5~30.5 kg/m^2 and the body weight must be over 55 kg(men) or 45 kg(women) (Body mass index (BMI) = weight (kg) / height (m)^2) .
  • Individuals with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area.
  • Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc.
  • The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs.
  • Individuals who agreed proper contraception during the study
  • The participants must have an ability and willingness to participate throughout the entire trials.

Who cannot join

  • Individuals with a medical evidence or a history (excluding dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease.
  • Individual who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy).
  • Individual who had following results after examination(a. ALT or AST > twice higher than Upper limit of normal value).
  • Individual Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250 mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (12%) (125 mL) = 12g).
  • Individual whose blood pressure < 90 or ≥160(systolic blood pressure) or < 50 or ≥ 100(diastolic blood pressure).
  • Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within 180 days prior to the first dose of this study(except when subject have not taken investigational product(s)).
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  • Individual who had a medical history of alcohol and drug abuses.
  • Individual who had taken a drug that has a control of metabolic rate (activation or inhibition) in 30 days before the first taking of clinical testing drug.
  • Individual who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders.
  • A person who is not determined unsuitable to participate in this test by the researchers.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Min-gul Kim

    Jeonju, Korea

Other trials in South Korea

About this study

Official title: An Open-label, Multiple Dose, Crossover Study to Evaluate the Drug-drug Interaction Between AJU-A51R1 and AJU-A51R2 in Healthy Volunteers

To evaluate a pharmacokinetic drug interaction between AJU-A51R1 and AJU-A51R2 in healthy male volunteers.

Read the detailed description

This study is to investigate drug-drug interaction between AJU-A51R1 and AJU-A51R2.

Being tested
Treatment A, Treatment B, Treatment C
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.

  • Treatment ADrug

    Also called Period 1

    AJU-A51R1: Farxiga 1 Tab., Q.D., single dose, for 5 days

  • Treatment BDrug

    Also called Period 2

    AJU-A51R2: Trajenta 1 Tab., Q.D., single dose, for 11 days

  • Treatment CDrug

    Also called Period 3

    AJU-A51R1 1 Tab. and AJU-A51R2 1 Tab., Q.D., co-administration for 5 days

Study groups in NCT04970940
Study groupRoleWhat they receive
Sequence 1Experimental* Period 1: Treatment A(AJU-A51R1: Farxiga 1 Tab., Q.D., single dose, for 5 days) * Wash-out for 7 days * Period 2: Treatment B(AJU-A51R2: Trajenta 1 Tab., Q.D., single dose, for 11 days) * Period 3: Treatment C(AJU-A51R1 1 Tab. and AJU-A51R2 1 Tab., Q.D., co-administration for 5 days)
Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCτ of AJU-A51R1 and AJU-A51R2

    Area Under Curve tau

    Measured: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose

  2. Css,max of AJU-A51R1 and AJU-A51R2

    Cmax, steady state

    Measured: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2021
  2. Study start2 Jul 2020
  3. Primary completion7 Oct 2020
  4. Study completion31 Dec 2020

Resources

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
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04970940
Sponsor's protocol ID
20DM10201
Status last verified
Jul 2021
First submitted
12 Jul 2021
Last updated
21 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with T2DM (Type 2 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 7 inclusion and 10 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 21 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?

AUCτ of AJU-A51R1 and AJU-A51R2 (time frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours 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?

On the ClinicalTrials.gov record for NCT04970940.

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 21 Jul 2021.

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