Phase I Drug-drug Interaction of Omega-3 and Atorvastatin

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hyperlipidemia, Hypertriglyceridemia

Intervention / Treatment
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* Drug: Omacor
* Drug: Pritor
* Drug: Omacor + Pritor
* Drug: Pritor + Omacor


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>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. | Drug: Omacor<br>* Omacor soft capsule 4000mg for 16days<br>Drug: Omacor + Pritor<br>* Omacor soft capsule 4000mg + Pritor tablet 40mg for 7days<br>|
| Experimental: Cohort B<br>Administration of Pritor tablet 40mg for 7 days, and followed by Pritor tablet 40mg and Omacor soft capsule 4000mg in combination for 16 days. | Drug: Pritor<br>* Pritor tablet 40mg for 7days<br>Drug: Pritor + Omacor<br>* Pritor tablet 40mg + Omacor soft capsule 4000mg for 16dyas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 
| Cohort B | Area under curve(0-t) of Atorvastatin | 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 |