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

NCT01964365 | Completed Phase 1

• 1 other identifier: DW_DWJ1330001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax

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

• AUCtau

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

Secondary Outcomes (5)

• Cmin

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

• Tmax

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

• CL/F

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

• T1/2

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

• Metabolic Ratio

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

Study Arms (3)

Rosuvastatin

EXPERIMENTAL

multiple dose of Rosuvastatin 20mg

Drug: Cresto 20mg

Fenofibric acid

EXPERIMENTAL

multiple dose of Fenofibric acid 135mg

Drug: Fenofibric acid 135mg

Rosuvastatin + Fenofibric acid

EXPERIMENTAL

multiple dose of the combination of Rosuvastatin 20mg and Fenofibric acid 135mg

Drug: Cresto 20mg, Fenofibric acid 135mg

Interventions

Cresto 20mg DRUG

tablet, rosuvastatin 20mg

Rosuvastatin

Fenofibric acid 135mg DRUG

capsule, fenofibric acid 135mg

Fenofibric acid

Cresto 20mg, Fenofibric acid 135mg DRUG

rosuvastatin 20mg, Fenofibric acid 135mg

Rosuvastatin + Fenofibric acid

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Inje University College of Medicine Busan Paik Hospital

Busan, South Korea

Location

MeSH Terms

Interventions

fenofibric acid

Study Officials

• Jae-Gook Shin, Professor

  BUSAN PAIK HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 17, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 13, 2014

Record last verified: 2013-10

Locations

KR (1)