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

NCT03438955 | Unknown Phase 1 DMC

• 1 other identifier: 17OA-15003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia, Hypertriglyceridemia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cohort A

EXPERIMENTAL

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; Drug: Omacor + Pritor

Cohort B

EXPERIMENTAL

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; Drug: Pritor + Omacor

Interventions

Omacor DRUG

Omacor soft capsule 4000mg for 16days

Cohort A

Pritor DRUG

Pritor tablet 40mg for 7days

Cohort B

Omacor + Pritor DRUG

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

Cohort A

Pritor + Omacor DRUG

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

Cohort B

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• kg 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

Sponsors & Collaborators

• DongKoo Bio & Pharma: lead

Study Sites (1)

Dong-A National University Hospital

Busan, 49201, South Korea

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias; Hypertriglyceridemia

Interventions

Omacor; Telmisartan

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Min Kyu Park, MD

  Dong-A National Univ. Hos.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Kyu Park, MD

CONTACT

+82 51 240 5180; minkpark@dau.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 20, 2018
• Study Start: February 1, 2018
• Primary Completion: July 31, 2018
• Study Completion: August 31, 2018
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)