Open-label, randomized comparative study to evaluate the pharmacokinetic characteristics of fenofibric acid between Lipidilsupra tablet and
Not Applicable
Recruiting
- Conditions
- Not Applicable
- Registration Number
- KCT0000323
- Lead Sponsor
- Hanmi Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 28
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC of Fenofibric acid;Cmax of Fenofibric acid
- Secondary Outcome Measures
Name Time Method Tmax of Fenofibric acid