Hyperlipidemia, Hypertriglyceridemia
Conditions
Brief summary
This study evaluates the safety and pharmacokinetic drug-drug interactions of omega-3 and atorvastatin in healthy male volunteers. Half of the participants will receive omega-3 for 16 days to be steady state of omega-3 and followed by omega-3 and atorvastatin in combination for 7 days. The other half will receive Atorvastatin for 7 days to be steady state of Atorvastatin, and followed by Atorvastatin and Omega-3 in combination for 16 days.
Interventions
DRUGOmacor
Omacor soft capsule 4000mg for 16days
DRUGPritor
Pritor tablet 40mg for 7days
DRUGOmacor + Pritor
Omacor soft capsule 4000mg + Pritor tablet 40mg for 7days
DRUGPritor + Omacor
Pritor tablet 40mg + Omacor soft capsule 4000mg for 16dyas
Sponsors
DongKoo Bio & Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 50kg or less of body weight and body mass index of 18 \ 30kg/m² * No congenital or chronic disease requiring treatment, and no pathological symptoms or findings as a result of medical examination * Eligible for the clinical trial as a result of a clinical laboratory test, 12-lead ECG, V/S test at the screening
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort A | Day 1 -20hours, -16hours, -12hours, 0hours, Day 13, 14, 15 0hours, Day 16 0, 1, 2, 3, 4, 6, 8, 12, 24hours, Day 23 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24hours | Area under curve(0-t) of EPA total lipid and Docosahexaenoic acid total lipid AUC t,ss and C max, ss of Atorvastatin |
| Cohort B | Day 1 0hours, Day 5, 6 0hours, Day 7 0, 0.25 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12 ,24hours, Day 23 0, 0.25, 0.5, 0.75, 1, 1.25, 2, 3, 4, 6, 8, 12, 24hours | Area under curve(0-t) of Atorvastatin |
Countries
South Korea
Contacts
Primary ContactMin Kyu Park, MD
Outcome results
None listed