Type 2 Diabetes MellitusPhase 1NCT03848637
The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-375
A Phase 1 study testing CKD-375 and D387 in people with Type 2 Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical.
Trial summary
The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-375 and D387 in healthy adults. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- CKD-375 and D387
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2019to 1 May 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 19 to 55 years
- Females who are not pregnant or breastfeeding or who have surgical infertility
- Signed informed consent form
- Other inclusion criteria, as defined in the protocol
Who cannot join
- History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
- Clinical laboratory test values are outside the accepted normal range at Screening
- Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge.
- Subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first IP dosing to the last discharge.
- Participated in a clinical trial within 90 days prior to 1st IP dosing
- Not eligible to participate for the study at the discretion of Investigator
- Other exclusive inclusion criteria, as defined in the protocol
Trial locations and contacts
No sites are listed yet.
Kyung-Sang Yu, M.D.,Ph.D contact
About this study
Official title: A Randomized, Open-label, Single Dose, 2-period, 2-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-375 Tablet With D387 Tablet in Healthy Volunteers
The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-375 and D387 in healthy adults.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- CKD-375, D387
- 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-375Drug
Test drug
D387Drug
Reference drug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | * Period 1: D387 (reference drug)
* Period 2: CKD-387 (test drug) Receives: Drug: CKD-375; Drug: D387 |
| Group 2 | Experimental | * Period 1: CKD-387 (test drug)
* Period 2: D387 (reference drug) Receives: Drug: CKD-375; Drug: D387 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration of Empagliflozin
Cmax of Empagliflozin
Measured: Time Frame: 0 hour ~ 48 hour after drug administration
Maximum plasma concentration of Metformin
Cmax of Metformin
Measured: Time Frame: 0 hour ~ 48 hour after drug administration
Area under the plasma concentration of Empagliflozin-time curve from time zero to time of last measurable concentration
AUClast of Empagliflozin
Measured: Time Frame: 0 hour ~ 48 hour after drug administration
Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration
AUClast of Metformin
Measured: Time Frame: 0 hour ~ 48 hour after drug administration
Secondary outcomes (10)
Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity
AUCinf of Empagliflozin
Measured: 0 hour ~ 48 hour after drug administration
Area under the plasma concentration of Metformin-time curve from time zero to infinity
AUCinf of Metformin
Measured: 0 hour ~ 48 hour after drug administration
Time to reach maximum (peak) plasma concentration of Empagliflozin following drug administration
Tmax of Empagliflozin
Measured: 0 hour ~ 48 hour after drug administration
Time to reach maximum (peak) plasma concentration of Metformin following drug administration
Tmax of Metformin
Measured: 0 hour ~ 48 hour after drug administration
Half-life of Empagliflozin
t1/2 of Empagliflozin
Measured: 0 hour ~ 48 hour after drug administration
Half-life of Metformin
t1/2 of Metformin
Measured: 0 hour ~ 48 hour after drug administration
Apparent clearance of Empagliflozin
CL/F of Empagliflozin
Measured: 0 hour ~ 48 hour after drug administration
Apparent clearance of Metformin
CL/F of Metformin
Measured: 0 hour ~ 48 hour after drug administration
Apparent volume of distribution of Empagliflozin
Vd/F of Empagliflozin
Measured: 0 hour ~ 48 hour after drug administration
Apparent volume of distribution of Metformin
Vd/F of Metformin
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 posted21 Feb 2019
- Study start14 Apr 2019 (estimated)
- Primary completion24 Apr 2019 (estimated)
- Study completion1 May 2019 (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
- Kyung-Sang Yu, M.D., Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848637
- Sponsor's protocol ID
- 192BE18036
- Status last verified
- Mar 2019
- First submitted
- 19 Feb 2019
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, 2-period, 2-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-375 Tablet With D387 Tablet in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03848637
- Acronym / sponsor ID
- 192BE18036
- 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
- 14 Apr 2019 (estimated)
- Primary completion
- 24 Apr 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 21 Feb 2019 (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.
The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-375 and D387 in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: CKD-375, Drug: D387* Period 1: D387 (reference drug) * Period 2: CKD-387 (test drug) |
| Group 2 | Experimental | Drug: CKD-375, Drug: D387* Period 1: CKD-387 (test drug) * Period 2: D387 (reference drug) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults aged 19 to 55 years
- Females who are not pregnant or breastfeeding or who have surgical infertility
- Signed informed consent form
- Other inclusion criteria, as defined in the protocol
Key exclusion criteria (7 listed)
- History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
- Clinical laboratory test values are outside the accepted normal range at Screening
- Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge.
- Subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first IP dosing to the last discharge.
- Participated in a clinical trial within 90 days prior to 1st IP dosing
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-375Test drug | Drug | Group 1, Group 2 |
| D387Reference drug | Drug | Group 1, Group 2 |
Primary outcome
Maximum plasma concentration of Empagliflozin
Time frame: Time Frame: 0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin
Maximum plasma concentration of Metformin
Time frame: Time Frame: 0 hour ~ 48 hour after drug administration
Cmax of Metformin
Area under the plasma concentration of Empagliflozin-time curve from time zero to time of last measurable concentration
Time frame: Time Frame: 0 hour ~ 48 hour after drug administration
AUClast of Empagliflozin
Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration
Time frame: Time Frame: 0 hour ~ 48 hour after drug administration
AUClast of Metformin
10 secondary outcomes
Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity
Time frame: 0 hour ~ 48 hour after drug administration
Area under the plasma concentration of Metformin-time curve from time zero to infinity
Time frame: 0 hour ~ 48 hour after drug administration
Time to reach maximum (peak) plasma concentration of Empagliflozin following drug administration
Time frame: 0 hour ~ 48 hour after drug administration
Time to reach maximum (peak) plasma concentration of Metformin following drug administration
Time frame: 0 hour ~ 48 hour after drug administration
Half-life of Empagliflozin
Time frame: 0 hour ~ 48 hour after drug administration
Half-life of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
Apparent clearance of Empagliflozin
Time frame: 0 hour ~ 48 hour after drug administration
Apparent clearance of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
Apparent volume of distribution of Empagliflozin
Time frame: 0 hour ~ 48 hour after drug administration
Apparent volume of distribution of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
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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.
Kyung-Sang Yu, M.D.,Ph.D contact
Kyung-Sang Yu, M.D., Ph.D principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-375 and D387 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 7 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 6 Mar 2019. 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 Kyung-Sang Yu, M.D.,Ph.D (+82-2-2072-1920), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration of Empagliflozin (time frame: Time Frame: 0 hour ~ 48 hour after drug administration). The study lists 4 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 6 Mar 2019.