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