Type2DiabetesPhase 1NCT05347576
A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions
A Phase 1 study testing CKD-393(2) and CKD-501, D759, D150, D029 in people with Type2Diabetes, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions Read more about this study
- Who is it for?
- Ages 19 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2Diabetes
- What is being tested?
- CKD-393(2) and CKD-501, D759, D150, D029
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Apr 2022to 9 May 2022
- 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 adult volunteers aged 19 ≤ ~ < 55-year-old.
- Weight ≥55kg (man) or 45kg (woman), with calculated body mass index(BMI) of 17.5 ≤ ~ < 30.5 kg/m2.
- Those who have no congenital diseases or chronic diseases within 3 years and have no abnormal symptoms or findings.
- Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
Who cannot join
- Those who have clinically significant disease or medical history of heart failure, Hepatopathy, Type 1 Diabetes, Diabetic ketoacidosis, Edema, Renal dysfunction, galactose intolerance, glucose-galactose malabsorption. And Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) during clinical trial.
- Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of investigational drug.
- Those who are pregnant or breastfeeding.
- Those who are deemed inappropriate to participate in clinical trial by investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions
A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions
Read the detailed description
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-393(2) in healthy volunteers under fed conditions
- Conditions
- Type2Diabetes
- Being tested
- CKD-393(2), CKD-501, D759, D150, D029
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-393(2)Drug
QD, PO
CKD-501, D759, D150, D029Drug
QD, PO
| Study group | Role | What they receive |
|---|---|---|
| sequence 1 | Experimental | Period 1- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition Period 2- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition Receives: Drug: CKD-393(2); Drug: CKD-501, D759, D150, D029 |
| sequence 2 | Experimental | Period 1- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition Period 2- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition Receives: Drug: CKD-393(2); Drug: CKD-501, D759, D150, D029 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Area under the concentration-time curve from time zero to time
Measured: Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours
Cmax
Maximum plasma concentration of the drug
Measured: Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start21 Apr 2022
- Primary completion2 May 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2DiabetesStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Gul Kim, M.D, Ph.D., Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347576
- Sponsor's protocol ID
- A98_07BE2201
- Status last verified
- Jun 2022
- First submitted
- 21 Apr 2022
- Last updated
- 30 Jun 2022
- 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 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT05347576
- Acronym / sponsor ID
- A98_07BE2201
- Conditions
- Type2Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 26 Apr 2022 (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.
A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions
Detailed description
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-393(2) in healthy volunteers under fed conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sequence 1 | Experimental | Drug: CKD-393(2), Drug: CKD-501, D759, D150, D029Period 1- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition Period 2- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition |
| sequence 2 | Experimental | Drug: CKD-393(2), Drug: CKD-501, D759, D150, D029Period 1- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition Period 2- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult volunteers aged 19 ≤ ~ < 55-year-old.
- Weight ≥55kg (man) or 45kg (woman), with calculated body mass index(BMI) of 17.5 ≤ ~ < 30.5 kg/m2.
- Those who have no congenital diseases or chronic diseases within 3 years and have no abnormal symptoms or findings.
- Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
Key exclusion criteria (4 listed)
- Those who have clinically significant disease or medical history of heart failure, Hepatopathy, Type 1 Diabetes, Diabetic ketoacidosis, Edema, Renal dysfunction, galactose intolerance, glucose-galactose malabsorption. And Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) during clinical trial.
- Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of investigational drug.
- Those who are pregnant or breastfeeding.
- Those who are deemed inappropriate to participate in clinical trial by investigators.
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-393(2)QD, PO | Drug | sequence 1, sequence 2 |
| CKD-501, D759, D150, D029QD, PO | Drug | sequence 1, sequence 2 |
Primary outcome
AUCt
Time frame: Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours
Area under the concentration-time curve from time zero to time
Cmax
Time frame: Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours
Maximum plasma concentration of the drug
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 30 Jun 2022.
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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.
Min Gul Kim, M.D, Ph.D. principal investigator
Chonbuk National University Hospital
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 CKD-393(2) and CKD-501, D759, D150, D029 in people with Type2Diabetes, run by Chong Kun Dang Pharmaceutical 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 4 inclusion and 4 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 30 Jun 2022. 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 (time frame: Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours). 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 30 Jun 2022.