Back to resultsPhase I Drug-drug Interaction of Omega-3 and Atorvastatin
Primary Purpose
Hyperlipidemia, Hypertriglyceridemia
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Omacor
Pritor
Omacor + Pritor
Pritor + Omacor
Sponsored by
About this trial
This is an interventional other trial for Hyperlipidemia, Hypertriglyceridemia
Eligibility Criteria
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:
-
Sites / Locations
- Dong-A National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort A
Cohort B
Arm Description
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.
Administration of Pritor tablet 40mg for 7 days, and followed by Pritor tablet 40mg and Omacor soft capsule 4000mg in combination for 16 days.
Outcomes
Primary Outcome Measures
Cohort A
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
Area under curve(0-t) of Atorvastatin
Secondary Outcome Measures
Full Information
NCT ID
NCT03438955
First Posted
February 8, 2018
Last Updated
February 20, 2018
Sponsor
DongKoo Bio & Pharma
1. Study Identification
Unique Protocol Identification Number
NCT03438955
Brief Title
Phase I Drug-drug Interaction of Omega-3 and Atorvastatin
Official Title
A Two-cohort, Single-sequence, Parallel, Open Label, Multiple Oral Dosing Phase I Study to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Omega-3 and Atorvastatin in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Anticipated)
Study Completion Date
August 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DongKoo Bio & Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Hypertriglyceridemia
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort A
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
Administration of Pritor tablet 40mg for 7 days, and followed by Pritor tablet 40mg and Omacor soft capsule 4000mg in combination for 16 days.
Intervention Type
Drug
Intervention Name(s)
Omacor
Intervention Description
Omacor soft capsule 4000mg for 16days
Intervention Type
Drug
Intervention Name(s)
Pritor
Intervention Description
Pritor tablet 40mg for 7days
Intervention Type
Drug
Intervention Name(s)
Omacor + Pritor
Intervention Description
Omacor soft capsule 4000mg + Pritor tablet 40mg for 7days
Intervention Type
Drug
Intervention Name(s)
Pritor + Omacor
Intervention Description
Pritor tablet 40mg + Omacor soft capsule 4000mg for 16dyas
Primary Outcome Measure Information:
Title
Cohort A
Description
Area under curve(0-t) of EPA total lipid and Docosahexaenoic acid total lipid AUC t,ss and C max, ss of Atorvastatin
Time Frame
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
Title
Cohort B
Description
Area under curve(0-t) of Atorvastatin
Time Frame
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Kyu Park, MD
Phone
+82 51 240 5180
Email
minkpark@dau.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Kyu Park, MD
Organizational Affiliation
Dong-A National Univ. Hos.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dong-A National University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Kyu Park
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase I Drug-drug Interaction of Omega-3 and Atorvastatin
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