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Completed

NCT Number: NCT01964365

Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and Fenofibric Acid in Healthy Male Volunteers

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and fenofibric acid in healthy adult subjects

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Inje University College of Medicine Busan Paik Hospital

Busan, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adult male volunteers aged 19 to 45 years
  • A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
  • A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints

Exclusion criteria

  • A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.
  • A subject who shows the following result in clinical laboratory test
  • AST, ALT > 1.25 times of the upper limit of normal range
  • PR ≥ 210 msec
  • QRS ≥ 120 msec
  • QT ≥ 500 msec
  • QTcF ≥ 500 msec
  • Subject who has taken other clinical medication from another clinical trial within 60-day period prior to the first administration of the study medication

Treatment and study plan

Cresto 20mg

Drug

tablet, rosuvastatin 20mg

Fenofibric acid 135mg

Drug

capsule, fenofibric acid 135mg

Cresto 20mg, Fenofibric acid 135mg

Drug

rosuvastatin 20mg, Fenofibric acid 135mg

Primary outcomes

  1. Cmax

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

  2. AUCtau

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

Secondary outcomes

  1. Cmin

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

  2. Tmax

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

  3. CL/F

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

  4. T1/2

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

  5. Metabolic Ratio

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Rosuvastatin and Fenofibric Acid in Healthy Adult Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 17, 2013
Registry last updated
Feb 13, 2014

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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