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

Phase 1

• Conditions: Hyperlipidemia, Hypertriglyceridemia
• Interventions: Drug: Pritor; Drug: Omacor; Drug: Omacor + Pritor; Drug: Pritor + Omacor

• Registration Number: NCT03438955
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-02
• Study Start: 2018-02-01
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-18
• Study First Posted: 2018-02-20
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22
• Primary Completion: 2018-07-31
• Study Completion: 2018-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort B	Pritor	Administration of Pritor tablet 40mg for 7 days, and followed by Pritor tablet 40mg and Omacor soft capsule 4000mg in combination for 16 days.
Cohort A	Omacor + Pritor	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.
Cohort B	Pritor + Omacor	Administration of Pritor tablet 40mg for 7 days, and followed by Pritor tablet 40mg and Omacor soft capsule 4000mg in combination for 16 days.
Cohort A	Omacor	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.

Primary Outcome Measures

Name	Time	Method
Cohort A	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
Cohort B	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

Trial Locations

Locations (1)

Dong-A National University Hospital; 🇰🇷 Busan, Korea, Republic of