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

NCT03438955 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-02-22

No results posted yet for this study

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.

Conditions

  • Hyperlipidemia, Hypertriglyceridemia

Interventions

DRUG

Omacor

Omacor soft capsule 4000mg for 16days

DRUG

Pritor

Pritor tablet 40mg for 7days

DRUG

Omacor + Pritor

Omacor soft capsule 4000mg + Pritor tablet 40mg for 7days

DRUG

Pritor + Omacor

Pritor tablet 40mg + Omacor soft capsule 4000mg for 16dyas

Sponsors & Collaborators

  • DongKoo Bio & Pharma

    lead INDUSTRY

Principal Investigators

  • Min Kyu Park, MD · Dong-A National Univ. Hos.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2018-07-31
Completion
2018-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03438955 on ClinicalTrials.gov