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

D

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)

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

Trial contacts and locations

1

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Central trial contact

Min Kyu Park, MD

Data sourced from clinicaltrials.gov

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