NCT01353404

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Samyang Biopharmaceuticals Corporation · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Sequence 1	fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral
DRUG	Sequence 2	fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral
DRUG	Seqeunce 3	fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral
DRUG	Sequence 4	fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral
DRUG	Sequence 5	fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral
DRUG	Sequence 6	fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-05-13
• Last updated: 2012-12-18

Locations

1 site across 1 country: South Korea