Type 2 Diabetes MellitusPhase 1NCT06483243
Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic of CKD-501, D745, and D150 for Healthy Subjects in Fed State.
A Phase 1 study testing Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG in people with Type 2 Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This is a Randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of CKD-383 and the co-administration of CKD-501, D745, and D150 for healthy subjects in fed state Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Apr 2024to 17 May 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 19 to 65 years
- Based on screening, no congenital or chronic disease, who have no athological symptoms or findings(If necessary, EEG, ECG, chest and gastroscopy or gastrointestinal radiation, Examination)
- within 5 years prior to the start of the trial(Period 1 administration) of any clinically significant mental medical history
- 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
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Oral Dosing, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D745, and D150 for Healthy Subjects in Fed State
This is a Randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of CKD-383 and the co-administration of CKD-501, D745, and D150 for healthy subjects in fed state
Read the detailed description
Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 or 4 tablets in single dose: actual medication)
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG
- 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.
Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MGDrug
Also called Test: CKD-383, Reference1: CKD-501, Reference2: D745, Reference3: D150
At around 8 a.m., take Test drug or Reference drug 1,2,3(oral) with 200 mL of water at room temperature.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | * Phase 1: CKD-501 1 tablet, D745 1 tablet, D150 2 tablets(Reference)
* Phase 2: CKD-383 2 tablets(Test) Receives: Drug: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG |
| Group B | Experimental | * Phase 1: CKD-383 2 tablets(Test)
* Phase 2: CKD-501 1 tablet, D745 1 tablet, D150 2 tablets(Reference) Receives: Drug: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of Lobeglitazone, Empagliflozin, Metformin
Pharmacokinetic characterization
Measured: 0 hour ~ 48 hour after drug administration
Cmax of Lobeglitazone, Empagliflozin, Metformin
Pharmacokinetic characterization
Measured: 0 hour ~ 48 hour after drug administration
Secondary outcomes (5)
AUC∞ of Lobeglitazone, Empagliflozin, Metformin
Pharmacokinetic characterization
Measured: 0 hour ~ 48 hour after drug administration
Tmax of Lobeglitazone, Empagliflozin, Metformin
Pharmacokinetic characterization
Measured: 0 hour ~ 48 hour after drug administration
T1/2 of Lobeglitazone, Empagliflozin, Metformin
Pharmacokinetic characterization
Measured: 0 hour ~ 48 hour after drug administration
CL/F of Lobeglitazone, Empagliflozin, Metformin
Pharmacokinetic characterization
Measured: 0 hour ~ 48 hour after drug administration
Vd/F of Lobeglitazone, Empagliflozin, Metformin
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 posted3 Jul 2024
- Study start4 Apr 2024
- Primary completion29 Apr 2024
- Study completion17 May 2024
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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yun Hwan Oh, PI, Principal investigator, Chung-Ang University Gwangmyeong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483243
- Sponsor's protocol ID
- A101_05BE2315
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Oral Dosing, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D745, and D150 for Healthy Subjects in Fed State
- ClinicalTrials.gov ID
- NCT06483243
- Acronym / sponsor ID
- A101_05BE2315
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 3 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 oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of CKD-383 and the co-administration of CKD-501, D745, and D150 for healthy subjects in fed state
Detailed description
Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 or 4 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 A | Experimental | Drug: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG* Phase 1: CKD-501 1 tablet, D745 1 tablet, D150 2 tablets(Reference) * Phase 2: CKD-383 2 tablets(Test) |
| Group B | Experimental | Drug: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG* Phase 1: CKD-383 2 tablets(Test) * Phase 2: CKD-501 1 tablet, D745 1 tablet, D150 2 tablets(Reference) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults aged 19 to 65 years
- Based on screening, no congenital or chronic disease, who have no athological symptoms or findings(If necessary, EEG, ECG, chest and gastroscopy or gastrointestinal radiation, Examination)
- within 5 years prior to the start of the trial(Period 1 administration) of any clinically significant mental medical history
- Other inclusion criteria, as defined in the protocol
Key exclusion criteria (2 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 |
|---|---|---|
| Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MGAlso: Test: CKD-383, Reference1: CKD-501, Reference2: D745, Reference3: D150At around 8 a.m., take Test drug or Reference drug 1,2,3(oral) with 200 mL of water at room temperature. | Drug | Group A, Group B |
Primary outcome
AUCt of Lobeglitazone, Empagliflozin, Metformin
Time frame: 0 hour ~ 48 hour after drug administration
Pharmacokinetic characterization
Cmax of Lobeglitazone, Empagliflozin, Metformin
Time frame: 0 hour ~ 48 hour after drug administration
Pharmacokinetic characterization
5 secondary outcomes
AUC∞ of Lobeglitazone, Empagliflozin, Metformin
Time frame: 0 hour ~ 48 hour after drug administration
Tmax of Lobeglitazone, Empagliflozin, Metformin
Time frame: 0 hour ~ 48 hour after drug administration
T1/2 of Lobeglitazone, Empagliflozin, Metformin
Time frame: 0 hour ~ 48 hour after drug administration
CL/F of Lobeglitazone, Empagliflozin, Metformin
Time frame: 0 hour ~ 48 hour after drug administration
Vd/F of Lobeglitazone, Empagliflozin, 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 3 Jul 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
Chronic Kidney Disease, Hypertension (HTN)
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
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Yun Hwan Oh, PI principal investigator
Chung-Ang University Gwangmyeong 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 Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG in people with Type 2 Diabetes Mellitus, 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 2 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 3 Jul 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 Lobeglitazone, Empagliflozin, 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?
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 3 Jul 2024.