Phase I Drug-drug Interaction of Omega-3 and Atorvastatin
NCT ID: NCT03438955
Last Updated: 2018-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
48 participants
INTERVENTIONAL
2018-02-01
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Cohort A
Administration of omacor soft capsule 4000mg for 16 days, and followed by omacor soft capsule 4000mg and Pritor tablet 40mg in combination for 7 days.
Omacor
Omacor soft capsule 4000mg for 16days
Omacor + Pritor
Omacor soft capsule 4000mg + Pritor tablet 40mg for 7days
Cohort B
Administration of Pritor tablet 40mg for 7 days, and followed by Pritor tablet 40mg and Omacor soft capsule 4000mg in combination for 16 days.
Pritor
Pritor tablet 40mg for 7days
Pritor + Omacor
Pritor tablet 40mg + Omacor soft capsule 4000mg for 16dyas
Interventions
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Omacor
Omacor soft capsule 4000mg for 16days
Pritor
Pritor tablet 40mg for 7days
Omacor + Pritor
Omacor soft capsule 4000mg + Pritor tablet 40mg for 7days
Pritor + Omacor
Pritor tablet 40mg + Omacor soft capsule 4000mg for 16dyas
Eligibility Criteria
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Inclusion Criteria
* 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
19 Years
45 Years
MALE
Yes
Sponsors
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DongKoo Bio & Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Min Kyu Park, MD
Role: PRINCIPAL_INVESTIGATOR
Dong-A National Univ. Hos.
Locations
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Dong-A National University Hospital
Busan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Min Kyu Park
Role: primary
Other Identifiers
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17OA-15003
Identifier Type: -
Identifier Source: org_study_id
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