Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of HIP0901 Capsule
NCT ID: NCT01555398
Last Updated: 2013-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2012-02-29
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Fasting conditions
Investigational product administrated under fasting condition.
HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions
The study drug(HIP0901 capsule(Fenofibric acid, 135mg)) will be administrated under fed or fasting conditions
Fed conditions
Investigational product administrated 30min after starting a high-fat breakfast.
HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions
The study drug(HIP0901 capsule(Fenofibric acid, 135mg)) will be administrated under fed or fasting conditions
Interventions
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HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions
The study drug(HIP0901 capsule(Fenofibric acid, 135mg)) will be administrated under fed or fasting conditions
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
45 Years
MALE
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Ji-Young Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Locations
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Korea University Anam Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HM-FEN-102
Identifier Type: -
Identifier Source: org_study_id
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