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

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sequence 1
Sequence 2
Seqeunce 3
Sequence 4
Sequence 5
Sequence 6
Sponsored by
Samyang Biopharmaceuticals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Clinical Research Institute, Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

fenofibrate 65mg, fed condition, per oral

fenofibrate 65mg, fasting condition, per oral

fenofibrate 160mg, fed condition, per oral

Arm Description

Outcomes

Primary Outcome Measures

Bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg)

Secondary Outcome Measures

Full Information

First Posted
May 12, 2011
Last Updated
December 16, 2012
Sponsor
Samyang Biopharmaceuticals Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01353404
Brief Title
Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg)
Official Title
Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg) in Normal Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samyang Biopharmaceuticals Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fenofibrate 65mg, fed condition, per oral
Arm Type
Experimental
Arm Title
fenofibrate 65mg, fasting condition, per oral
Arm Type
Experimental
Arm Title
fenofibrate 160mg, fed condition, per oral
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sequence 1
Intervention Description
fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral
Intervention Type
Drug
Intervention Name(s)
Sequence 2
Intervention Description
fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral
Intervention Type
Drug
Intervention Name(s)
Seqeunce 3
Intervention Description
fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral
Intervention Type
Drug
Intervention Name(s)
Sequence 4
Intervention Description
fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral
Intervention Type
Drug
Intervention Name(s)
Sequence 5
Intervention Description
fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral
Intervention Type
Drug
Intervention Name(s)
Sequence 6
Intervention Description
fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral
Primary Outcome Measure Information:
Title
Bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg)
Time Frame
23 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-Sang Yu, M.D., Ph.D., M.B.A.
Organizational Affiliation
Clinical Research Institute, Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Institute, Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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