Type II DiabetesPhase 1NCT05741437
A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-378
A Phase 1 study testing CKD-378, QD, PO Drug: D745, D150, QD, PO in people with Type II Diabetes, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-378 Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- CKD-378, QD, PO Drug: D745, D150, QD, PO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Apr 2023to 5 Sep 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
- Healthy adult aged between 19 to 55 at screening
- Weight ≥ 50kg(man) or 50kg(woman)
- Body mass index (BMI) of 18.5 to 27.0kg/m2
- If female, one of following conditions. Menopause (no menstruation more than 2 years) or surgically sterilized.
- Those who agree to contraception from the first IP dosing day till 28 days after the last dosing day and decide not to provide sperm during the participation of clinical trial
- Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial
Who cannot join
- Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Haemato-oncology disorder, Cardiovascular disorder or Psychical disorder.
- Those who are vulnerable to dehydration due to lack of ability in oral intake or have dehydration.
- Those who had medical examination requiring radioactive iodine contrast material injected through IV 48 hours prior to first IP administration.
- Those who have significant disease or medical history of urinary infection.
- Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption.
Show all 23Show fewer
- Those who have hypersensitivity to the main constituents or components of the investigational drug such as empagliflozin, metformin.
- Those who have tested inappropriate in screening test 28 days prior to IP administration.
- AST, ALT > 1.5 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 >150 mmHg or or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg.
- Those who has a drug abuse history within one year or positive reaction on urine drug screening test.
- Woman who are pregnant or breastfeeding
- Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 210g/week, smoking> 10 cigarettes/day) and not able to stop on smoking, caffeine and alcohol
- Those who have used following drugs that can interfere with the study or have impact on safety of the subject.
- ETC, herbal medicinal preparations within 14 days before the first dosing date
- OTC, vitamins, health supplement within 7 days before the first dosing date
- Depot injection or implantation within 30 days before the first dosing date
- Those who received investigational products or participated in bioequivalence test within 180 days before the first administration of clinical trial drugs
- Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days
- Those who have received blood transfusion in 30 days
- Those who are deemed insufficient to participate in clinical study by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150 in Healthy Adults
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-378
Read the detailed description
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety after Oral Administration of CKD-378 and Co-administration of D745, D150 in Healthy Adults
- Conditions
- Type II Diabetes
- Being tested
- CKD-378, QD, PO Drug: D745, D150, QD, PO
- Keywords
- CKD-378
- 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-378, QD, PO Drug: D745, D150, QD, PODrug
Also called CKD-378
Durg: CKD-378, QD, PO Drug: D745, D150, QD, PO
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | * Period 1: D745, D150 - A single oral dose of 2 tablets under food intake condition
* Period 2: CKD-378 - A single oral dose of 1 tablet under food intake condition Receives: Drug: CKD-378, QD, PO Drug: D745, D150, QD, PO |
| Sequence 2 | Experimental | * Period 1: CKD-378 - A single oral dose of 1 tablet under food intake condition
* Period 2: D745, D150 - A single oral dose of 2 tablets under food intake condition Receives: Drug: CKD-378, QD, PO Drug: D745, D150, QD, PO |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. AUCt of CKD-378: Area under the concentration-time curve time zero to time
Measured: Pre-dose(0 hour) to 48 hours
2. Cmax of CKD-378: Maximum plasma concentration of the drug
Measured: Pre-dose(0 hour) to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start11 Apr 2023
- Primary completion31 Aug 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741437
- Sponsor's protocol ID
- A129_01BE2225
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2023
- Last updated
- 12 Mar 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150 in Healthy Adults
- ClinicalTrials.gov ID
- NCT05741437
- Acronym / sponsor ID
- A129_01BE2225
- Conditions
- Type II Diabetes
- Keywords
- CKD-378
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 23 Feb 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.
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-378
Detailed description
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety after Oral Administration of CKD-378 and Co-administration of D745, D150 in Healthy Adults
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-378, QD, PO Drug: D745, D150, QD, PO* Period 1: D745, D150 - A single oral dose of 2 tablets under food intake condition * Period 2: CKD-378 - A single oral dose of 1 tablet under food intake condition |
| Sequence 2 | Experimental | Drug: CKD-378, QD, PO Drug: D745, D150, QD, PO* Period 1: CKD-378 - A single oral dose of 1 tablet under food intake condition * Period 2: D745, D150 - A single oral dose of 2 tablets under food intake condition |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult aged between 19 to 55 at screening
- Weight ≥ 50kg(man) or 50kg(woman)
- Body mass index (BMI) of 18.5 to 27.0kg/m2
- If female, one of following conditions. Menopause (no menstruation more than 2 years) or surgically sterilized.
- Those who agree to contraception from the first IP dosing day till 28 days after the last dosing day and decide not to provide sperm during the participation of clinical trial
Key exclusion criteria (23 listed)
- Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Haemato-oncology disorder, Cardiovascular disorder or Psychical disorder.
- Those who are vulnerable to dehydration due to lack of ability in oral intake or have dehydration.
- Those who had medical examination requiring radioactive iodine contrast material injected through IV 48 hours prior to first IP administration.
- Those who have significant disease or medical history of urinary infection.
- Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
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-378, QD, PO Drug: D745, D150, QD, POAlso: CKD-378Durg: CKD-378, QD, PO Drug: D745, D150, QD, PO | Drug | Sequence 1, Sequence 2 |
Primary outcome
1. AUCt of CKD-378: Area under the concentration-time curve time zero to time
Time frame: Pre-dose(0 hour) to 48 hours
2. Cmax of CKD-378: Maximum plasma concentration of the drug
Time frame: Pre-dose(0 hour) to 48 hours
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 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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-378, QD, PO Drug: D745, D150, QD, PO in people with Type II 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 6 inclusion and 23 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 Mar 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?
1. AUCt of CKD-378: Area under the concentration-time curve time zero to time (time frame: Pre-dose(0 hour) to 48 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 12 Mar 2024.