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

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353404
• Other study ID #: SYO0805
• Status: Completed
• Phase: Phase 1
• First received: May 12, 2011
• Last updated: December 16, 2012
• Start date: June 2011
• Est. completion date: August 2011

Study information

• Verified date: December 2012
• Source: Samyang Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Sequence 1
fenofibrate 65mg, fed condition, per oral ? fenofibrate 65mg, fasting condition, per oral ? fenofibrate 160mg, fed condition, per oral
• Sequence 2
fenofibrate 65mg, fed condition, per oral ? fenofibrate 160mg, fed condition, per oral ? fenofibrate 65mg, fasting condition, per oral
• Seqeunce 3
fenofibrate 65mg, fasting condition, per oral ? fenofibrate 160mg, fed condition, per oral ? fenofibrate 65mg, fed condition, per oral
• Sequence 4
fenofibrate 65mg, fasting condition, per oral ? fenofibrate 65mg, fed condition, per oral ? fenofibrate 160mg, fed condition, per oral
• Sequence 5
fenofibrate 160mg, fed condition, per oral ? fenofibrate 65mg, fed condition, per oral ? fenofibrate 65mg, fasting condition, per oral
• Sequence 6
fenofibrate 160mg, fed condition, per oral ? fenofibrate 65mg, fasting condition, per oral ? fenofibrate 65mg, fed condition, per oral

Locations

Country	Name	City	State
Korea, Republic of	Clinical Research Institute, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg)		23 days	No