Type 2 Diabetes MellitusPhase 1NCT06492655
To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers
A Phase 1 study testing CKD-383(Fed) and CKD-383(Fasted) in people with Type 2 Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical.
Trial summary
This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 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-383(Fed) and CKD-383(Fasted)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 4 Jul 2024to 8 Aug 2024
- 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
- who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period
- 1 administration)
- Other exclusive criteria, as defined in the protocol
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover, Phase 1 Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-383 in Healthy Volunteers
This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers
Read the detailed description
Participants were randomly assigned in a 1:1 ratio. TheParticipants are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- CKD-383(Fed), CKD-383(Fasted)
- 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-383(Fed)Drug
Also called Lobeglitazone, Empagliflozin, Metformin
After maintaining NPO for at least 10 hours before a high-fat meal, take a high-fat meal within 20 minutes on each medication day, and take CKD-383 two tablets orally with 150 mL of water at room temperature.
CKD-383(Fasted)Drug
Also called Lobeglitazone, Empagliflozin, Metformin
After maintaining NPO for at least 10 hours before dosing, and take CKD-383 two tablets orally with 150 mL of room temperature water with 30g of sugar added on each dosing day.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | * Period 1: CKD-383 two tablets(Fed)
* Period 2: CKD-383 two tablets(Fasted) Receives: Drug: CKD-383(Fed); Drug: CKD-383(Fasted) |
| Group 2 | Other | * Period 1: CKD-383 two tablets(Fasted)
* Period 2: CKD-383 two tablets(Fed) Receives: Drug: CKD-383(Fed); Drug: CKD-383(Fasted) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
Pharmacokinetic characterization
Measured: 0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
Pharmacokinetic characterization
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 posted9 Jul 2024
- Study start4 Jul 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion8 Aug 2024 (estimated)
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaeyong chung, PI, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492655
- Sponsor's protocol ID
- A101_06FDI2404
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Crossover, Phase 1 Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-383 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06492655
- Acronym / sponsor ID
- A101_06FDI2404
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 8 Aug 2024 (estimated)
- First posted
- 9 Jul 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 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers
Detailed description
Participants were randomly assigned in a 1:1 ratio. TheParticipants 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 | Other | Drug: CKD-383(Fed), Drug: CKD-383(Fasted)* Period 1: CKD-383 two tablets(Fed) * Period 2: CKD-383 two tablets(Fasted) |
| Group 2 | Other | Drug: CKD-383(Fed), Drug: CKD-383(Fasted)* Period 1: CKD-383 two tablets(Fasted) * Period 2: CKD-383 two tablets(Fed) |
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 (3 listed)
- who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period
- 1 administration)
- Other exclusive 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-383(Fed)Also: Lobeglitazone, Empagliflozin, MetforminAfter maintaining NPO for at least 10 hours before a high-fat meal, take a high-fat meal within 20 minutes on each medication day, and take CKD-383 two tablets orally with 150 mL of water at room temperature. | Drug | Group 1, Group 2 |
| CKD-383(Fasted)Also: Lobeglitazone, Empagliflozin, MetforminAfter maintaining NPO for at least 10 hours before dosing, and take CKD-383 two tablets orally with 150 mL of room temperature water with 30g of sugar added on each dosing day. | Drug | Group 1, Group 2 |
Primary outcome
AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
Time frame: 0 hour ~ 48 hour after drug administration
Pharmacokinetic characterization
Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
Time frame: 0 hour ~ 48 hour after drug administration
Pharmacokinetic characterization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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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 chung, PI principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-383(Fed) and CKD-383(Fasted) in people with Type 2 Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical.
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 3 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jisoo Kim, PL (02-6373-0785, jisoo.kim@ckdpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2) (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?
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 10 Jul 2024.