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

• Status: Unknown status
• Trial end date: 2018-08-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: DongKoo Bio & Pharma
• Treatments: Atorvastatin Calcium; Telmisartan

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:

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