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NCT Number: NCT01353404

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

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Institute, Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sequence 1

Drug

fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral

Sequence 2

Drug

fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral

Seqeunce 3

Drug

fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral

Sequence 4

Drug

fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral

Sequence 5

Drug

fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral

Sequence 6

Drug

fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral

Primary outcomes

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

    Time frame: 23 days

Sponsors and collaborators

Lead sponsor

Samyang Biopharmaceuticals Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 13, 2011
Registry last updated
Dec 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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