Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg)

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg) in single dose oral administration.

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

Details

• Lead Sponsor: Samyang Biopharmaceuticals Corporation
• Treatments: Fenofibrate

Criteria

Inclusion Criteria:

• Healthy adults 20-50 years of age

• Weight more than 55kg and within ±20% IBW(Ideal Body Weight)

• Voluntary written informed consent

Exclusion Criteria:

• History or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease

• Drug allergies to fenofibrate

• Recent history or evidence of drug abuse

• Recent participation(within 2months) in other clinical studies

• Recent donation of blood(within 2months) or plasma(within 1months)