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Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects (sibu)

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ClinicalTrials.gov Identifier: NCT01421706
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : September 18, 2012
Sponsor:
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University

Tracking Information
First Submitted Date  ICMJE August 22, 2011
First Posted Date  ICMJE August 23, 2011
Last Update Posted Date September 18, 2012
Study Start Date  ICMJE July 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2012)
effects of clopidogrel and clarithromycin on the disposition of sibutramine [ Time Frame: one year ]
the effects of clopidogrel and clarithromycin on the disposition of sibutramine and its two active metabolites M1 and M2 in vivo in relation to CYP2B6*6 genetic polymorphism have been evaluated in Korean healthy subjects.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01421706 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 Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects
Official Title  ICMJE Effects of Clopidogrel and Clarithromycin on the Disposition of Sibutramine and Its Active Metabolites M1 and M2 in Relation to CYP2B6*6 Polymorphism
Brief Summary Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects
Detailed Description 1. Plasma concentrations of sibutramine and its two active metabolites after single oral dose of sibutramine were determined in Korean healthy male subjects with different CYP2B6 genotypes (CYP2B6*1/*1, *1/*6 and *6/*6), either alone or after four-day pretreatment with clopidogrel or clarithromycin.
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: Sibutramine-clopidogrel
    Sibutramine-clopidogrel
  • Drug: sibutramine-Clarithromycin
    sibutramine-Clarithromycin
Study Arms  ICMJE
  • Active Comparator: sibutramine-clopidogrel
    sibutramine-clopidogrel
    Intervention: Drug: Sibutramine-clopidogrel
  • Active Comparator: sibutramine-clarithromycin
    sibutramine-clarithromycin
    Intervention: Drug: sibutramine-Clarithromycin
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: September 16, 2012)
20
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • must be healthy volunteer

Exclusion Criteria:

  • must not be under 18 years old
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01421706
Other Study ID Numbers  ICMJE 08-073
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jae-Gook Shin, Inje University
Study Sponsor  ICMJE Inje University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: JaeGook Shin, MD,PhD Inje University
PRS Account Inje University
Verification Date September 2012

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