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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:
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
ClinicalTrials.gov Identifier:
NCT01421706
First received: August 22, 2011
Last updated: September 16, 2012
Last verified: September 2012

August 22, 2011
September 16, 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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Sibutramine-clopidogrel
    Sibutramine-clopidogrel
    Other Name: Sibutramine-clopidogrel
  • Drug: sibutramine-Clarithromycin
    sibutramine-Clarithromycin
    Other Name: sibutramine-Clarithromycin
  • Active Comparator: sibutramine-clopidogrel
    sibutramine-clopidogrel
    Intervention: Drug: Sibutramine-clopidogrel
  • Active Comparator: sibutramine-clarithromycin
    sibutramine-clarithromycin
    Intervention: Drug: sibutramine-Clarithromycin
Not Provided

*   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
Male
19 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01421706
08-073
No
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