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

DongKoo Bio & Pharma

Status and phase: Unknown; Phase 1

Conditions: Hyperlipidemia, Hypertriglyceridemia

Treatments: Drug: Omacor + Pritor; Drug: Omacor; Drug: Pritor + Omacor; Drug: Pritor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03438955

17OA-15003

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Cohort A

Experimental group

Description:

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.

Treatment:

Drug: Omacor

Drug: Omacor + Pritor

Cohort B

Experimental group

Description:

Administration of Pritor tablet 40mg for 7 days, and followed by Pritor tablet 40mg and Omacor soft capsule 4000mg in combination for 16 days.

Treatment:

Drug: Pritor

Drug: Pritor + Omacor