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Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of HIP0901 Capsule

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01555398
First received: March 13, 2012
Last updated: April 5, 2013
Last verified: April 2013
History of Changes

March 13, 2012
April 5, 2013
February 2012
March 2012   (final data collection date for primary outcome measure)
  • AUC of Fenofibric acid [ Time Frame: 0-96 hrs ] [ Designated as safety issue: No ]
  • Cmax of Fenofibric acid [ Time Frame: 0-96 hrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01555398 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of HIP0901 Capsule
Open-label, Randomized Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Fenofibric Acid for HIP0901 Capsule in Healthy Male Subjects

The purpose of this study is to evaluate the effect of food on the pharmacokinetic characteristics of fenofibric acid for HIP0901 capsule.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Dietary Supplement: HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions
The study drug(HIP0901 capsule(Fenofibric acid, 135mg)) will be administrated under fed or fasting conditions
  • Experimental: Fasting conditions
    Investigational product administrated under fasting condition.
    Intervention: Dietary Supplement: HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions
  • Active Comparator: Fed conditions
    Investigational product administrated 30min after starting a high-fat breakfast.
    Intervention: Dietary Supplement: HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male volunteers, age between 20 and 45
  • Informed of the investigational nature of this study and voluntarily agree to participate in this study
  • Weight＞50kg, BMI of ＞18kg/m2 and ＜27kg/m2 subject

Exclusion Criteria:

  • Acute disease within 28 days prior to start of study drug administration
  • Use of any prescription medication within 14 days prior to Day 1
  • Use of any medication within 7 days prior to Day 1
  • Has a severe medical history of hypersensitivity to fibric acid derivative
  • Participation in another clinical study within 30 days prior to start of study drug administration
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01555398
HM-FEN-102
No
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Principal Investigator: Ji-Young Park, MD, PhD Korea University Anam Hospital
Hanmi Pharmaceutical Company Limited
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP