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

February 20, 2018 updated by: DongKoo Bio & Pharma

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Recruiting
        • Dong-A National University Hospital
        • Contact:
          • Min Kyu Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Omacor
Omacor soft capsule 4000mg for 16days
Drug: Omacor + Pritor
Omacor soft capsule 4000mg + Pritor tablet 40mg for 7days
EXPERIMENTAL: 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.
Drug: Pritor
Pritor tablet 40mg for 7days
Drug: Pritor + Omacor
Pritor tablet 40mg + Omacor soft capsule 4000mg for 16dyas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort A
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DongKoo Bio & Pharma

Investigators

  • Principal Investigator: Min Kyu Park, MD, Dong-A National Univ. Hos.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2018

Primary Completion (ANTICIPATED)

July 31, 2018

Study Completion (ANTICIPATED)

August 31, 2018

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

February 18, 2018

First Posted (ACTUAL)

February 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17OA-15003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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