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

Phase 1

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Sequence 1; Drug: Sequence 2; Drug: Seqeunce 3; Drug: Sequence 4; Drug: Sequence 5; Drug: Sequence 6

• Registration Number: NCT01353404
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-12
• Study First Posted: 2011-05-13
• Study Start: 2011-06
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-16
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
fenofibrate 65mg, fed condition, per oral	Sequence 6	-
fenofibrate 65mg, fed condition, per oral	Sequence 1	-
fenofibrate 65mg, fed condition, per oral	Sequence 2	-
fenofibrate 65mg, fed condition, per oral	Seqeunce 3	-
fenofibrate 65mg, fed condition, per oral	Sequence 4	-
fenofibrate 65mg, fed condition, per oral	Sequence 5	-
fenofibrate 65mg, fasting condition, per oral	Sequence 1	-
fenofibrate 65mg, fasting condition, per oral	Sequence 2	-
fenofibrate 65mg, fasting condition, per oral	Seqeunce 3	-
fenofibrate 65mg, fasting condition, per oral	Sequence 4	-
fenofibrate 65mg, fasting condition, per oral	Sequence 5	-
fenofibrate 65mg, fasting condition, per oral	Sequence 6	-
fenofibrate 160mg, fed condition, per oral	Sequence 1	-
fenofibrate 160mg, fed condition, per oral	Sequence 2	-
fenofibrate 160mg, fed condition, per oral	Seqeunce 3	-
fenofibrate 160mg, fed condition, per oral	Sequence 4	-
fenofibrate 160mg, fed condition, per oral	Sequence 5	-
fenofibrate 160mg, fed condition, per oral	Sequence 6	-

Primary Outcome Measures

Name	Time	Method
Bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg)	23 days

Trial Locations

Locations (1)

Clinical Research Institute, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of