Trial | NCT03438955  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    48
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.
Study Started
Feb 01
2018
Primary Completion
Jul 31
2018
Anticipated
Study Completion
Aug 31
2018
Anticipated
Last Update
Feb 22
2018

Drug Omacor

Omacor soft capsule 4000mg for 16days

Drug Pritor

Pritor tablet 40mg for 7days

Drug Omacor + Pritor

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

Drug Pritor + Omacor [telmisartan (micardis), omega-3 fatty acids (Omacor)]

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

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.

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.

Criteria 

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:

-
No Results Posted