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

Information source: Inje University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Sibutramine-clopidogrel (Drug); sibutramine-Clarithromycin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Inje University

Official(s) and/or principal investigator(s):
JaeGook Shin, MD,PhD, Principal Investigator, Affiliation: Inje University


Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects

Clinical Details

Official title: Effects of Clopidogrel and Clarithromycin on the Disposition of Sibutramine and Its Active Metabolites M1 and M2 in Relation to CYP2B6*6 Polymorphism

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: effects of clopidogrel and clarithromycin on the disposition of sibutramine

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.


Minimum age: 19 Years. Maximum age: 55 Years. Gender(s): Male.


Inclusion Criteria:

- must be healthy volunteer

Exclusion Criteria:

- must not be under 18 years old

Locations and Contacts

Additional Information

Starting date: July 2008
Last updated: September 16, 2012

Page last updated: August 23, 2015

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