Dyslipidemias, Hypertension
Conditions
Keywords
CKD-386, Pharmacokinetics, D326, D337, D013
Brief summary
a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
Detailed description
A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
Interventions
A single oral dose of 1 tablet under fasting conditions for each period
A single oral dose of 1 tablet under fasting conditions for each period
DRUGD326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy volunteers aged between ≥20 and ≤45 years old 2. Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2 3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings 4. Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests 5. 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. History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug 2. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption 3. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013 | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 | Cmax: Maximum plasma concentration of the drug |
| AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013 | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 | AUC0-t: Area under the concentration-time curve from time zero to time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 | t1/2: Terminal elimination half-life |
| CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 | CL/F: Apparent total body clearance of the drug |
| AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | 0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31 | AUCinf: Area under the concentration-time curve from zero up to ∞ |
| AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 | AUC0-t: Area under the concentration-time curve from time zero to time |
| Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 | Cmax: Maximum plasma concentration of the drug |
| Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 | Vd/F: Apparent volume of distribution |
| Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 | 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 | Tmax: Time to maximum plasma concentration |
Countries
South Korea
Contacts
Primary ContactDongseong Shin, M.D, Ph.D
Outcome results
None listed