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Completed

NCT Number: NCT01555398

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

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

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Anam Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions

Dietary Supplement

The study drug(HIP0901 capsule(Fenofibric acid, 135mg)) will be administrated under fed or fasting conditions

Primary outcomes

  1. AUC of Fenofibric acid

    Time frame: 0-96 hrs

  2. Cmax of Fenofibric acid

    Time frame: 0-96 hrs

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

Open-label, Randomized Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Fenofibric Acid for HIP0901 Capsule in Healthy Male Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 15, 2012
Registry last updated
Apr 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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