Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of HIP0901 Capsule
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Dietary Supplement: HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions
- Registration Number
- NCT01555398
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
The purpose of this study is to evaluate the effect of food on the pharmacokinetic characteristics of fenofibric acid for HIP0901 capsule.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
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 Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fasting conditions HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions Investigational product administrated under fasting condition. Fed conditions HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions Investigational product administrated 30min after starting a high-fat breakfast.
- Primary Outcome Measures
Name Time Method AUC of Fenofibric acid 0-96 hrs Cmax of Fenofibric acid 0-96 hrs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of