Dyslipidemias, Hypertension
Conditions
Keywords
CKD-348
Brief summary
A clinical trial to compare the pharmacokinetics and tolerability of CKD-348
Detailed description
A randomized, open-label, single-dose, 3-way crossover clinical trial to compare the pharmacokinetics and tolerability of CKD-348 with co-administrated drugs in healthy adult volunteers
Interventions
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 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult volunteers aged ≥ 19-year-old 2. Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2 3. Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg 4. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings 5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests 6. Those who agree to contraception during the participation of clinical trial 7. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
Exclusion criteria
1. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug 2. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug 3. Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month 4. Those who has a history of gastrointestinal surgery ( 5. Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day 6. Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency 7. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption 8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests 9. Women who are pregnant or who may be pregnant and breastfeed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt of CKD-348 | Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | AUCt: Area under the concentration-time curve from time zero to time |
| Cmax of CKD-348 | Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | Cmax: Maximum plasma concentration of the drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf of CKD-348 | Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | AUCinf: Area under the concentration-time curve from zero up to ∞ |
| Tmax of CKD-348 | Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | Tmax: Time to maximum plasma concentration |
| t1/2 of CKD-348 | Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | t1/2: Terminal elimination half-life |
| AUCt/AUCinf of CKD-348 | Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | AUCt/AUCinf |
Countries
South Korea
Outcome results
None listed