Dyslipidemias, Hypertension
Conditions
Keywords
Dyslipidemia, Hypertension, CKD-386, Drug-Drug Interaction
Brief summary
A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
Detailed description
An open-label, randomized, multiple-dose crossover study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
Interventions
DRUGD013, D326 and D337
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
DRUGD013
Daily oral administration of 1 tablet under fasting conditions for 7 days
DRUGD326 and D337
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy volunteers aged between ≥ 20 and ≤ 45 years old 2. Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m² 3. Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm 4. Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study
Exclusion criteria
1. History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder 2. With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration 3. Any medical history that may affect drug absorption, distribution, metabolism and excretion 4. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder 5. Any clinically significant active chronic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state) | 0(predose)~24 hours at Day7 and Day28 | * Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing |
| Cmax,ss(Maximum plasma concentration of the drug at steady state) | 0(predose)~24 hours at Day7 and Day28 | * Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax,ss(Time to maximum plasma concentration at steady state) | 0(predose)~24 hours at Day7 and Day28 | * Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing |
| t1/2(Terminal elimination half-life) | 0(predose)~24 hours at Day7 and Day28 | * Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing |
| Vd,ss/F(Apparent volume of distribution at steady state) | 0(predose)~24 hours at Day7 and Day28 | * Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing |
| PTF(Peak-to-trough fluctuation) | 0(predose)~24 hours at Day7 and Day28 | * Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing |
| CLss/F(Apparent total body clearance of the drug from plasma at steady state) | 0(predose)~24 hours at Day7 and Day28 | * Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing |
| Cmin,ss(Minimum concentration of the drug in plasma at steady state) | 0(predose)~24 hours at Day7 and Day28 | * Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing |
Countries
South Korea
Outcome results
None listed