Type 2 DiabetesPhase 1NCT05816759
Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D744, and D150
A Phase 1 study testing CKD-383 and CKD-501, D744, D150 in people with Type 2 Diabetes, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D744, and D150 for Healthy Subjects in Fed State Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CKD-383 and CKD-501, D744, D150
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2023to 22 Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
- Healthy adult who aged 19 to 55 years.
- Those who meet the criteria of anthropometric data
- Man: Body weight ≥ 50 kg, Body mass index 18 to 30 kg/m2
- Woman: Body weight ≥ 45 kg, Body mass index 18 to 30 kg/m2
Who cannot join
- Those who have medical history of hypersensitivity to active pharmaceutical ingredient (Lobeglitazone, Sitagliptin, Metformin) or additives.
- Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Digestive system disorder, Endocrine system disorder, Cardiovascular disorder, Blood tumor, Psychical disorder, Severe urinary tract infection.
- 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 drug.
- Those who have Drug abuse (especially sleeping drugs, central analgesics, opiates or psychotropic drugs such as psychotropic drugs) or persons with a history of substance abuse.
- Those who have the test results written below
- AST, ALT > 2 times higher than upper normal level
Show all 22Show fewer
- Total bilirubin > 2 times higher than upper normal level
- eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2
- "Positive" or "Reactive" test result of Hepatitis B \& C, HIV, RPR
- Under 5 min resting condition, systolic blood pressure >160 mmHg or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg
- Those who have determined that the abnormal results are clinically significant in the screening test items (question, vital signs, electrocardiogram, physical test, blood, urine test, etc.).
- Those who participated in other clinical trials within 180 days of the intended study drug administration and have been administered clinical trial medications (except for those who have not taken the study medication).
- Those who has taken a drug (Ethical drug, over the counter drug, herbal medicine, or nutritional supplement (vitamin, etc.)) within 14 days prior to screening (however, if it is considered that it does not affect the safety and research results of the subject, as determined by the investigator).
- Those who donated whole blood within 8 weeks prior to screening, or who donated or donated components (plasma, platelets) within 4 weeks, and consented to prohibit blood donation from 30 days after the last administration of investigational product.
- Those who have continuously consumed more than 21 units/week (1 unit of alcohol = 10 g = 12.5 mL) within 6 months prior to screening.
- Those who have More than 10 smokers a day within 6 months prior to screening.
- Those who cannot use clinically acceptable contraceptive methods (e.g., infertility surgery between themselves and partners, intrauterine contraceptive devices, use of diaphragms or condoms) from the time the drug is administered to the last visit.
- Those who cannot inhibit the diet (especially grapefruit juice, caffeine) that can affect the absorption, distribution, metabolism, and excretion of the drug from 3 days before the last administration of the investigational product to the last visit.
- Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
- Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48 hours before the first administration of investigational product.
- 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.
South Korea1 site
CHA Bundang Medical Center, CHA University
Seongnam-si, Bundang, 13497
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, D744, and D150 for Healthy Subjects in Fed State
Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D744, and D150 for Healthy Subjects in Fed State
- Conditions
- Type 2 Diabetes
- Being tested
- CKD-383, CKD-501, D744, D150
- 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-383Drug
QD, PO
CKD-501, D744, D150Drug
QD, PO
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1: CKD-383 (A single oral dose of 1 tablet under fed condition) Period 2: CKD-501, D744, D150 (A single oral dose of 3 tablets under fed condition) Receives: Drug: CKD-383; Drug: CKD-501, D744, D150 |
| Sequence B | Experimental | Period 1: CKD-501, D744, D150 (A single oral dose of 3 tablets under fed condition) Period 2: CKD-383 (A single oral dose of 1 tablet under fed condition) Receives: Drug: CKD-383; Drug: CKD-501, D744, D150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of CKD-383
Cmax: Maximum plasma concentration of the drug
Measured: Pre-does(0 hour), Post-dose(0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour)
AUCt of CKD-383
AUCt: Area under the concentration-time curve from time zero to time
Measured: Pre-does(0 hour), Post-dose(0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start26 May 2023
- Primary completion4 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anhye Kim, Ph.D, Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816759
- Sponsor's protocol ID
- A101_04BE2113
- Status last verified
- Jan 2024
- First submitted
- 5 Apr 2023
- Last updated
- 23 Jan 2024
- 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 23 Jan 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, D744, and D150 for Healthy Subjects in Fed State
- ClinicalTrials.gov ID
- NCT05816759
- Acronym / sponsor ID
- A101_04BE2113
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 26 May 2023 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 18 Apr 2023 (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.
Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D744, and D150 for Healthy Subjects in Fed State
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: CKD-383, Drug: CKD-501, D744, D150Period 1: CKD-383 (A single oral dose of 1 tablet under fed condition) Period 2: CKD-501, D744, D150 (A single oral dose of 3 tablets under fed condition) |
| Sequence B | Experimental | Drug: CKD-383, Drug: CKD-501, D744, D150Period 1: CKD-501, D744, D150 (A single oral dose of 3 tablets under fed condition) Period 2: CKD-383 (A single oral dose of 1 tablet under fed condition) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
- Healthy adult who aged 19 to 55 years.
- Those who meet the criteria of anthropometric data
Key exclusion criteria (22 listed)
- Those who have medical history of hypersensitivity to active pharmaceutical ingredient (Lobeglitazone, Sitagliptin, Metformin) or additives.
- Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Digestive system disorder, Endocrine system disorder, Cardiovascular disorder, Blood tumor, Psychical disorder, Severe urinary tract infection.
- 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 drug.
- Those who have Drug abuse (especially sleeping drugs, central analgesics, opiates or psychotropic drugs such as psychotropic drugs) or persons with a history of substance abuse.
- Those who have the test results written below
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-383QD, PO | Drug | Sequence A, Sequence B |
| CKD-501, D744, D150QD, PO | Drug | Sequence A, Sequence B |
Primary outcome
Cmax of CKD-383
Time frame: Pre-does(0 hour), Post-dose(0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour)
Cmax: Maximum plasma concentration of the drug
AUCt of CKD-383
Time frame: Pre-does(0 hour), Post-dose(0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour)
AUCt: Area under the concentration-time curve from time zero to time
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 23 Jan 2024.
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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.
Anhye Kim, Ph.D principal investigator
CHA University
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-383 and CKD-501, D744, D150 in people with Type 2 Diabetes, 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 5 inclusion and 22 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 23 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?
Cmax of CKD-383 (time frame: Pre-does(0 hour), Post-dose(0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour)). 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 23 Jan 2024.