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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438955
Recruitment Status : Unknown
Verified February 2018 by DongKoo Bio & Pharma.
Recruitment status was:  Recruiting
First Posted : February 20, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
DongKoo Bio & Pharma

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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia, Hypertriglyceridemia Drug: Omacor Drug: Pritor Drug: Omacor + Pritor Drug: Pritor + Omacor Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Telmisartan

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




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438955


Contacts
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Contact: Min Kyu Park, MD +82 51 240 5180 minkpark@dau.ac.kr

Locations
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Korea, Republic of
Dong-A National University Hospital Recruiting
Busan, Korea, Republic of, 49201
Contact: Min Kyu Park         
Sponsors and Collaborators
DongKoo Bio & Pharma
Investigators
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Principal Investigator: Min Kyu Park, MD Dong-A National Univ. Hos.
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Responsible Party: DongKoo Bio & Pharma
ClinicalTrials.gov Identifier: NCT03438955    
Other Study ID Numbers: 17OA-15003
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperlipidemias
Hypertriglyceridemia
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action