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Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02089399
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Tracking Information
First Submitted Date  ICMJE March 14, 2014
First Posted Date  ICMJE March 17, 2014
Last Update Posted Date April 29, 2015
Study Start Date  ICMJE May 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2014)
  • AUCtau [ Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment ]
  • Css,max [ Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2014)
  • Tss,max [ Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment ]
  • Css,min [ Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult Volunteers
Official Title  ICMJE An Open Label, Randomized, 2-Sequence, Multiple-Dose, Cross-Over Study to Investigate the Drug-Drug Interaction of Sevikar and Crestor in Healthy Adult Volunteers
Brief Summary The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Sevikar(amlodipne/olmesartan)
    Treatment AB
  • Drug: crestor(Rosuvastatin)
    Treatment AB/Treatment C
Study Arms  ICMJE
  • Experimental: Treatment AB
    S->S+C
    Interventions:
    • Drug: Sevikar(amlodipne/olmesartan)
    • Drug: crestor(Rosuvastatin)
  • Experimental: Treatment C
    C
    Intervention: Drug: crestor(Rosuvastatin)
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 14, 2014)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects aged 19 - 55 years
  • A body mass index in the range 19 - 27 kg/m2
  • Willingness to participate during the entire study period
  • Written informed consent after being fully informed about the study procedures

Exclusion Criteria:

  • Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
  • History of clinically significant drug hypersensitivity
  • Use of medication within 7 days before the first dose
  • Heavy drinker (>140 g/week)
  • Whole blood donation during 60 days before the study
  • Judged not eligible for study participation by investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02089399
Other Study ID Numbers  ICMJE DW_DWJ1351001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daewoong Pharmaceutical Co. LTD.
Study Sponsor  ICMJE Daewoong Pharmaceutical Co. LTD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daewoong Pharmaceutical Co. LTD.
Verification Date April 2015

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