NCT01555398
Completed
Phase 1
Open-label, Randomized Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Fenofibric Acid for HIP0901 Capsule in Healthy Male Subjects
Hanmi Pharmaceutical Company Limited1 site in 1 country48 target enrollmentFebruary 2012
ConditionsHealthy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- AUC of Fenofibric acid
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effect of food on the pharmacokinetic characteristics of fenofibric acid for HIP0901 capsule.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
AUC of Fenofibric acid
Time Frame: 0-96 hrs
Cmax of Fenofibric acid
Time Frame: 0-96 hrs
Study Sites (1)
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