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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01353404
First Posted: May 13, 2011
Last Update Posted: December 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation
  Purpose
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.

Condition Intervention Phase
Hyperlipidemia Drug: Sequence 1 Drug: Sequence 2 Drug: Seqeunce 3 Drug: Sequence 4 Drug: Sequence 5 Drug: Sequence 6 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg) in Normal Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Samyang Biopharmaceuticals Corporation:

Primary Outcome Measures:
  • Bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg) [ Time Frame: 23 days ]

Enrollment: 24
Study Start Date: June 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fenofibrate 65mg, fed condition, per oral 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
Experimental: fenofibrate 65mg, fasting condition, per oral 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
Active Comparator: fenofibrate 160mg, fed condition, per oral 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353404


Locations
Korea, Republic of
Clinical Research Institute, Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
Investigators
Principal Investigator: Kyung-Sang Yu, M.D., Ph.D., M.B.A. Clinical Research Institute, Seoul National University Hospital
  More Information

Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01353404     History of Changes
Other Study ID Numbers: SYO0805
First Submitted: May 12, 2011
First Posted: May 13, 2011
Last Update Posted: December 18, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents