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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions

Study type: Interventional

Funder types: Industry

Identifiers

NCT01555398

HM-FEN-102

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of food on the pharmacokinetic characteristics of fenofibric acid for HIP0901 capsule.

Enrollment: 48 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Fasting conditions

Experimental group

Description:

Investigational product administrated under fasting condition.

Treatment:

Dietary Supplement: HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions

Fed conditions

Active Comparator group

Description:

Investigational product administrated 30min after starting a high-fat breakfast.

Treatment:

Dietary Supplement: HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions