Diabetes Mellitus, Type II
Conditions
Keywords
Diabetes Mellitus, Type II
Brief summary
Phase 1 trial to evaluate the drug drug interaction of CKD-501 and D308
Detailed description
A randomized, open-label, multiple dose, 2-way crossover study to evaluate the drug drug interaction of CKD-501 and D308 in healthy volunteers
Interventions
DRUGD308, CKD-501
1. D308 2. CKD-501: Lobeglitazone sulfate 0.5mg
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult older than 19 years at the time of screening 2. BMI 17.5\ 30.5kg/m2 and body weight more than 55kg 3. Subject who has no chronic disease within last 3 years and no symptoms or pathological findings 4. Suitable subject who is determined to be suitable at the time of screening such as laboratory tests(hematology, blood chemistry, urinalysis, virus/bacteriological test, etc.), sign of vitality, electrocardiogram 5. Subject who signed the written consent of the Chonbuk National University Hospital IRB to participate in this study with full understanding of the purpose and contents of the examination prior to the clinical trial 6. Subject who has will and ability to participate in clinical trials
Exclusion criteria
1. Subject who has a history of clinical significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological or allergic diseases(except for asymptomatic seasonal allergies not treated at the time of administration) or evidence(except for simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.) 2. Subject with a history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption 3. Clinical laboratory test results showing the following values \* ALT or AST \> 2 times upper limit of normal range 4. Subject who has a history of regular alcohol consumption exceeding 210g/week within 6months of screening (1 glass of beer(5%)=10g, 1 glass of soju(20%)=8g, 1 glass of wine(12%)=12g) 5. Those taking other clinical trial drugs or bioequivalence test drugs within 3months before the first administration of clinical trial drug 6. Subject who has a systolic blood pressure of less than 100mmHg or more than 140mmHg or diastolic blood pressure of less than 60mmHg or more than 90mmHg of screening 7. Subject who has significant alcohol abuse or drug abuse within a year of screening 8. Those taking medication known to significantly induce or inhibit drug metabolizing enzymes within 30days prior to the first administration of clinical trial medication 9. More than 20 smokers per day within six months of screening 10. Those taking prescription or non-prescription drugs within 10days before the first administration of clinical trial medication 11. Those who donated whole blood within 2 months or those who donated the components within 1 month before the first administration of the clinical trial drug 12. Subject who has risk of serious or chronic medical, mental, or laboratory examinations that may increase the risk due to the administration of medicines for clinical trials and may interfere with the interpretation of test results 13. Patients who are known to be hypersensitive to the drug or its components 14. Patients with severe heart failure or heart failure(New York Heart Association(NYHA) Class 3, 4 heart patients) 15. Patients with hepatic impairment 16. Patients with a glomerular filtration rate(eGFR) less than 60ml/min/1.73m2, patients with end stage renal disease or dialysis 17. Patients with diabetic ketoacidosis, diabetic coma and total coma, patients with type 1 diabetes 18. Before and after surgery, severe infectious patients, severe trauma patients 19. Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 20. Pregnant and lactating women 21. Subject who is judged by the investigator to be ineligible to participate in the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (Part 1) AUCss,tau of D308 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Area under the curve of D308 at steady state |
| (Part 1) Css,max of D308 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Max Concentration of D308 at steady state |
| (Part 2) AUCss,tau of CKD-501 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Area under the curve of CKD-501 at steady state |
| (Part 2) Css,max of CKD-501 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Max Concentration of CKD-501 at steady state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| (Part 1) CLss/F of D308 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Apparent clearance of D308 at steady state |
| (Part 1) Vdss/F of D308 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Apparent volume of distribution of D308 at steady state |
| (Part 1) Fluctuation[(Css,max-Css,min)/Css,av] of D308 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Fluctuation concentration of D308 at steady state |
| (Part 1) Swing[(Css,max-Css,min)/Css,min] of D308 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Swing concentration of D308 at steady state |
| (Part 2) Css,min of CKD-501 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Min concentration of CKD-501 at steady state |
| (Part 2) Css,av of CKD-501 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | average concentration of CKD-501 at steady state |
| (Part 1) Css,min of D308 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Min concentration of D308 at steady state |
| (Part 2) t1/2 of CKD-501 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | half-life time of CKD-501 |
| (Part 2) CLss/F of CKD-501 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Apparent clearance of CKD-501 at steady state |
| (Part 2) Vdss/F of CKD-501 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Apparent volume of distribution of CKD-501 at steady state |
| (Part 2) Fluctuation[(Css,max-Css,min)/Css,av] of CKD-501 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Fluctuation concentration of CKD-501 at steady state |
| (Part 2) Swing[(Css,max-Css,min)/Css,min] of CKD-501 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | Swing concentration of CKD-501 at steady state |
| (Part 2) Tss,max of CKD-501 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | time of Max concentration of CKD-501 at steady state |
| (Part 1) Css,av of D308 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | average concentration of D308 at steady state |
| (Part 1) Tss,max of D308 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | time of Max concentration of D308 at steady state |
| (Part 1) t1/2 of D308 | Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | half-life time of D308 |
Countries
South Korea
Outcome results
None listed