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

Hyperlipidemia, Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03438955
• Other study ID #: 17OA-15003
• Status: Recruiting
• Phase: Phase 1
• First received: February 8, 2018
• Last updated: February 20, 2018
• Start date: February 1, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: February 2018
• Source: DongKoo Bio & Pharma
• Contact: Min Kyu Park, MD
• Phone: +82 51 240 5180
• Email: minkpark[@]dau.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: August 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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:

Related Conditions & MeSH terms

• Hyperlipidemia, Hypertriglyceridemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertriglyceridemia

Intervention

Drug:
• Omacor
Omacor soft capsule 4000mg for 16days
• Pritor
Pritor tablet 40mg for 7days
• Omacor + Pritor
Omacor soft capsule 4000mg + Pritor tablet 40mg for 7days
• Pritor + Omacor
Pritor tablet 40mg + Omacor soft capsule 4000mg for 16dyas

Locations

Country	Name	City	State
Korea, Republic of	Dong-A National University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
DongKoo Bio & Pharma

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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