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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01421706
First Posted: August 23, 2011
Last Update Posted: September 18, 2012
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.
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
August 22, 2011
August 23, 2011
September 18, 2012
July 2008
July 2009   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT01421706 on ClinicalTrials.gov Archive Site
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Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects
Effects of Clopidogrel and Clarithromycin on the Disposition of Sibutramine and Its Active Metabolites M1 and M2 in Relation to CYP2B6*6 Polymorphism
Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy
  • Drug: Sibutramine-clopidogrel
    Sibutramine-clopidogrel
  • Drug: sibutramine-Clarithromycin
    sibutramine-Clarithromycin
  • Active Comparator: sibutramine-clopidogrel
    sibutramine-clopidogrel
    Intervention: Drug: Sibutramine-clopidogrel
  • Active Comparator: sibutramine-clarithromycin
    sibutramine-clarithromycin
    Intervention: Drug: sibutramine-Clarithromycin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • must be healthy volunteer

Exclusion Criteria:

  • must not be under 18 years old
Sexes Eligible for Study: Male
19 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01421706
08-073
No
Not Provided
Not Provided
Jae-Gook Shin, Inje University
Inje University
Not Provided
Principal Investigator: JaeGook Shin, MD,PhD Inje University
Inje University
September 2012

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