Type 2 Diabetes MellitusPhase 1NCT06204107

A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379

A Phase 1 study testing CKD-379(Empagliflozin+sitagliptin+metformin) Test drug and CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug in people with Type 2 Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical 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

This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers Read more about this study

Who is it for?: Ages 19 to 54 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug and CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteSouth Korea
Study dates: 21 Nov 2023to 6 Dec 2023
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 to 54 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults aged 19 to 54 years
BMI measurement result is 18.0 kg/m2 to 30 kg/m2
Written informed consent
Other inclusion criteria, as defined in the protocol

Who cannot join

History of clinically significant liver, kidney, blood, digestive, respiratory, endocrine, cardiovascular, neurological, mental, or immune system disorders
AST or ALT or total bilirubin > 1.5 times the upper limit of normal range
History of regular alcohol consumption > 21 units/week within 6 months at the time of screening
Participated in a clinical trial within 6 months prior to 1st IP dosing
Other exclusive inclusion criteria, as defined in the protocol

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Bundang Hospital
Seongnam

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers

This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers

Read the detailed description

Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)

Conditions: Type 2 Diabetes Mellitus
Being tested: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug, CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
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.

CKD-379(Empagliflozin+sitagliptin+metformin) Test drugDrug
oral, once
CKD-379(Empagliflozin+sitagliptin+metformin) Reference drugDrug
oral, once

Study groups in NCT06204107
Study group	Role	What they receive
Group 1	Experimental	* Phase 1: CKD-379 Test drug * Phase 2: CKD-379 Reference drug Receives: Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug; Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
Group 2	Experimental	* Phase 1: CKD-379 Reference drug * Phase 2: CKD-379 Test drug Receives: Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug; Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug

What is being measured

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

AUCt of Empagliflozin, sitagliptin, metformin
Measured: 0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin, sitagliptin, metformin
Measured: 0 hour ~ 48 hour after drug administration

Secondary outcomes (5)

AUCinf of Empagliflozin, sitagliptin, metformin
Measured: 0 hour ~ 48 hour after drug administration
Tmax of Empagliflozin, sitagliptin, metformin
Measured: 0 hour ~ 48 hour after drug administration
t1/2 of Empagliflozin, sitagliptin, metformin
Measured: 0 hour ~ 48 hour after drug administration
CL/F of Empagliflozin, sitagliptin, metformin
Measured: 0 hour ~ 48 hour after drug administration
Vd/F of Empagliflozin, sitagliptin, 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.

21 Nov 20236 Dec 2023

First posted12 Jan 2024
Study start21 Nov 2023
Primary completion6 Dec 2023
Study completion6 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
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: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06204107
Sponsor's protocol ID: A125_05FDI2310
Status last verified: Jan 2024
First submitted: 17 Dec 2023
Last updated: 12 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers
ClinicalTrials.gov ID: NCT06204107
Acronym / sponsor ID: A125_05FDI2310
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 21 Nov 2023 (actual)
Primary completion: 6 Dec 2023 (actual)
Study completion: 6 Dec 2023 (actual)
First posted: 12 Jan 2024 (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.

This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers

Detailed description

Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug, Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug* Phase 1: CKD-379 Test drug * Phase 2: CKD-379 Reference drug
Group 2	Experimental	Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug, Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug* Phase 1: CKD-379 Reference drug * Phase 2: CKD-379 Test drug

Who may qualify

Ages: 19 to 54 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy adults aged 19 to 54 years
BMI measurement result is 18.0 kg/m2 to 30 kg/m2
Written informed consent
Other inclusion criteria, as defined in the protocol

Key exclusion criteria (5 listed)

History of clinically significant liver, kidney, blood, digestive, respiratory, endocrine, cardiovascular, neurological, mental, or immune system disorders
AST or ALT or total bilirubin > 1.5 times the upper limit of normal range
History of regular alcohol consumption > 21 units/week within 6 months at the time of screening
Participated in a clinical trial within 6 months prior to 1st IP dosing
Other exclusive inclusion criteria, as defined in the protocol

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
CKD-379(Empagliflozin+sitagliptin+metformin) Test drugoral, once	Drug	Group 1, Group 2
CKD-379(Empagliflozin+sitagliptin+metformin) Reference drugoral, once	Drug	Group 1, Group 2

Primary outcome

AUCt of Empagliflozin, sitagliptin, metformin
Time frame: 0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin, sitagliptin, metformin
Time frame: 0 hour ~ 48 hour after drug administration

5 secondary outcomes

AUCinf of Empagliflozin, sitagliptin, metformin
Time frame: 0 hour ~ 48 hour after drug administration
Tmax of Empagliflozin, sitagliptin, metformin
Time frame: 0 hour ~ 48 hour after drug administration
t1/2 of Empagliflozin, sitagliptin, metformin
Time frame: 0 hour ~ 48 hour after drug administration
CL/F of Empagliflozin, sitagliptin, metformin
Time frame: 0 hour ~ 48 hour after drug administration
Vd/F of Empagliflozin, sitagliptin, metformin
Time frame: 0 hour ~ 48 hour after drug administration

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 12 Jan 2024.
Individual participant dataSharing planned: No

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
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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.

Jaeyong Jeong principal investigator

Seoul National University Bundang Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 5 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 12 Jan 2024. 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 of Empagliflozin, sitagliptin, metformin (time frame: 0 hour ~ 48 hour after drug administration). 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 NCT06204107.

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 12 Jan 2024.