Type II DiabetesPhase 1NCT03646799
Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D484 in Healthy Adults
A Phase 1 study testing CKD-387 and D484 in people with Type II Diabetes, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability after Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg in Healthy Adults 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-387 and D484
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2018to 14 Sep 2018
- 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 volunteers between the ages of 19 and 55
- Body weight ≥ 55kg for male, ≥ 50kg for female
- Body mass index ≥ 18.5 kg/m2 and < 25.0 kg/m2
- Females who are post-menopausal or underwent sterilization
- Males who agreed to practice contraception until after 28 days of last intake Investigational product
- Ability to provide written informed consent
Who cannot join
- Subject with clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease and psychosis disorder
- Subject who are weak in dehydration or clinically significant dehydration
- IV injecting examination of radioactive-iodine substances within 48 hours prior to first IP administration
- Subjects who have Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Subjects with history of gastrointestinal disease or surgery that may affect absorption of IP
- Hypersensitive to dapagliflozin/metformin
Show all 19Show fewer
- At screening,
- AST(Aspartate Transaminase), ALT(Alanine Transaminase) > UNL(upper normal limit)*1.25
- Total Bilirubin > UNL(upper normal limit)*1.5, CPK > UNL(upper normal limit)*1.5
- eGFR(estimated Glomerular Filtration Rate) < 60 mL/min/1.73m2(Modification of diet in renal Disease calculated)
- Positive reaction on following tests: Hepatitis B, Hepatitis C, HIV(Human Immunodeficiency Virus) and syphilis
- SBP(Systolic blood pressure) ≥ 150 mmHg or < 90 mmHg, DBP(Diastolic blood pressure) > 100 mmHg or < 50 mmHg
- History of drug abuse or positive urine drug screening results
- Women with pregnant, breast-feeding
- Caffeine > 5 cups/day, Alcohol > 210 g/week, Smoker > 10 cigarettes /day or who are unable to stop caffeine intake, drinking alcohol and smoking until the last blood drawing for PK
- Subject who took ethical drug/herbal compound within 14 days, over-the-counter drug/vitamin supplements within 7 days and depot injection/implantation within 30 days prior to the first IP administration
- Subject who was enrolled in another clinical trial(including Bioequivalence study) and administered drugs within 90 days prior to the first IP administration
- Subject with whole blood donation within 60 days or component blood donation within 30 days
- Not eligible to participate for the study at the discretion of Investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Severance Hospital
Soeul
Min Soo Park, Ph.D. M.D, +82 2 2228 0400, minspark@yuhs.ac
Min Soo Park, Ph.D. M.D
About this study
Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg in Healthy Adults
Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability after Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg in Healthy Adults
- Conditions
- Type II Diabetes
- Being tested
- CKD-387, D484
- 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-387Drug
test drug
D484Drug
reference drug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Period 1: 1 tablet of reference drug(D484) Period 2: 1 tablet of test drug(CKD-387) Receives: Drug: CKD-387; Drug: D484 |
| Group 2 | Experimental | Period 1: 1 tablet of test drug(CKD-387) Period 2: 1 tablet of reference drug(D484) Receives: Drug: CKD-387; Drug: D484 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Dapagliflozin
Maximum plasma concentration of Dapagliflozin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Cmax of Metformin
Maximum plasma concentration of Metformin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
AUClast of Dapagliflozin
Area under the plasma concentration-time curve to last concentration of Dapagliflozin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
AUClast of Metformin
Area under the plasma concentration-time curve to last concentration of Metformin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Secondary outcomes (10)
AUCinf of Dapagliflozin
Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
AUCinf of Metformin
Area under the plasma concentration-time curve from zero to infinity concentration of Metformin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Tmax of Dapagliflozin
Time to maximum plasma concentration of Dapagliflozin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Tmax of Metformin
Time to maximum plasma concentration of Metformin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
T1/2 of Dapagliflozin
Half-life of Dapagliflozin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
T1/2 of Metformin
Half-life of Metformin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Vd/F of Dapagliflozin
Apparent volume of distribution of Dapagliflozin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Vd/F of Metformin
Apparent volume of distribution of Metformin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
CL/F of Dapagliflozin
Apparent clearance of Dapagliflozin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
CL/F of Metformin
Apparent clearance of Metformin
Measured: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 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 posted24 Aug 2018
- Study start30 Aug 2018 (estimated)
- Primary completion9 Sep 2018 (estimated)
- Study completion14 Sep 2018 (estimated)
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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Soo Park, Ph.D., Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646799
- Sponsor's protocol ID
- 184BE18012
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2018
- Last updated
- 24 Aug 2018
- 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 24 Aug 2018. 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/Tolerability After Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg in Healthy Adults
- ClinicalTrials.gov ID
- NCT03646799
- Acronym / sponsor ID
- 184BE18012
- Conditions
- Type II Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2018 (estimated)
- Primary completion
- 9 Sep 2018 (estimated)
- Study completion
- 14 Sep 2018 (estimated)
- First posted
- 24 Aug 2018 (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.
Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability after Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg 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-387, Drug: D484Period 1: 1 tablet of reference drug(D484) Period 2: 1 tablet of test drug(CKD-387) |
| Group 2 | Experimental | Drug: CKD-387, Drug: D484Period 1: 1 tablet of test drug(CKD-387) Period 2: 1 tablet of reference drug(D484) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy volunteers between the ages of 19 and 55
- Body weight ≥ 55kg for male, ≥ 50kg for female
- Body mass index ≥ 18.5 kg/m2 and < 25.0 kg/m2
- Females who are post-menopausal or underwent sterilization
- Males who agreed to practice contraception until after 28 days of last intake Investigational product
Key exclusion criteria (19 listed)
- Subject with clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease and psychosis disorder
- Subject who are weak in dehydration or clinically significant dehydration
- IV injecting examination of radioactive-iodine substances within 48 hours prior to first IP administration
- Subjects who have Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Subjects with history of gastrointestinal disease or surgery that may affect absorption of IP
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-387test drug | Drug | Group 1, Group 2 |
| D484reference drug | Drug | Group 1, Group 2 |
Primary outcome
Cmax of Dapagliflozin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Maximum plasma concentration of Dapagliflozin
Cmax of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Maximum plasma concentration of Metformin
AUClast of Dapagliflozin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Area under the plasma concentration-time curve to last concentration of Dapagliflozin
AUClast of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Area under the plasma concentration-time curve to last concentration of Metformin
10 secondary outcomes
AUCinf of Dapagliflozin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
AUCinf of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Tmax of Dapagliflozin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Tmax of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
T1/2 of Dapagliflozin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
T1/2 of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Vd/F of Dapagliflozin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Vd/F of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
CL/F of Dapagliflozin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
CL/F of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 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 24 Aug 2018.
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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.
Min Soo Park, Ph.D. principal investigator
Severance 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 CKD-387 and D484 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 19 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 24 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Soo Park, Ph.D. (82-2-2228-0270, minspark@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of Dapagliflozin (time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 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 24 Aug 2018.