Dyslipidemias, Hypertension
Conditions
Keywords
dyslipidemias, hypertension, Drug-Drug interaction
Brief summary
To evaluate pharmacokinetic properties and drug interactions between D326 and D337 co-administered groups, the CKD-828 alone and the total co-administered groups.
Interventions
DRUGSequence 1
D326, D337 or CKD-828 for 9 days
DRUGSequence 2
D326, D337 or CKD-828 for 9 days
DRUGSequence 3
D326, D337 or CKD-828 for 9 days
DRUGSequence 4
D326, D337 or CKD-828 for 9 days
DRUGSequence 5
D326, D337 or CKD-828 for 9 days
DRUGSequence 6
D326, D337 or CKD-828 for 9 days
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 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy volunteers aged between ≥ 19 and ≤ 40 years old 2. Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m² 3. Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial 4. Subject who agree not to provide sperm 5. Subject who voluntarily agree to participate in this study
Exclusion criteria
1. Any medical history that may affect drug absorption, distribution, metabolism and excretion 2. Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease. 3. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder 4. Subject who have received other clinical trial drugs within 90 days prior to the screening visit 5. Any clinically significant active chronic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax(Maximum plasma concentration of the drug at steady state) | at Day 9 | PK parameters of D326, D337 and CKD-828 |
| AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state) | at Day 9 | PK parameters of D326, D337 and CKD-828 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax(Time to maximum plasma concentration at steady state) | at Day 9 | PK parameters of D326, D337 and CKD-828 |
| t1/2(Terminal elimination half-life) | at Day 9 | PK parameters of D326, D337 and CKD-828 |
Countries
South Korea
Contacts
Primary ContactJihwan Oh
Outcome results
None listed