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to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers (NVP-1205)

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ClinicalTrials.gov Identifier: NCT02289430
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
Navipharm Corporation

Tracking Information
First Submitted Date  ICMJE November 9, 2014
First Posted Date  ICMJE November 13, 2014
Last Update Posted Date March 25, 2016
Study Start Date  ICMJE December 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2014)
Area Under Curve [ Time Frame: 0-24h ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2014)
AUC [ Time Frame: 0-24h ]
Change History Complete list of historical versions of study NCT02289430 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers
Official Title  ICMJE A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers
Brief Summary The purpose of this study is to compare the drug interaction of pharmacokinetics of rosuvastatin and ezetimibe.
Detailed Description drug interaction : rosuvastatin, ezetimibe
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Crestor+Ezetrol
    rosuvastatin+ezetimibe
    Other Name: rosuvatatin+ezetimibe
  • Drug: Ezetrol
    ezetimibe
    Other Name: ezetimibe
  • Drug: Crestor
    rosuvastatin
    Other Name: rosuvastatin
Study Arms  ICMJE
  • Experimental: Crestor+Ezetrol
    rosuvastatin+ezetimibe
    Intervention: Drug: Crestor+Ezetrol
  • Active Comparator: Ezetrol
    ezetimibe
    Intervention: Drug: Ezetrol
  • Active Comparator: Crestor
    rosuvastatin
    Intervention: Drug: Crestor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2016)
59
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2014)
28
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects age between 19 and 45 singed informed consent

Exclusion Criteria:

  • Hypotension or hypertension has a history of allergy reaction of this drug or other drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02289430
Other Study ID Numbers  ICMJE NVP-1205-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Navipharm Corporation
Study Sponsor  ICMJE Navipharm Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shin D Seong, M.D. Gachon University Gil Medical Center
PRS Account Navipharm Corporation
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP