Status:
UNKNOWN
Phase I Drug-drug Interaction of Omega-3 and Atorvastatin
Lead Sponsor:
DongKoo Bio & Pharma
Conditions:
Hyperlipidemia, Hypertriglyceridemia
Eligibility:
MALE
19-45 years
Phase:
PHASE1
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 stead...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03438955
Start Date
February 1 2018
End Date
August 31 2018
Last Update
February 22 2018
Active Locations (1)
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1
Dong-A National University Hospital
Busan, South Korea, 49201