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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01421706

Acronym

sibu

Enrollment

Registered

2011-08-23

Start date

2008-07-31

Completion date

2009-07-31

Last updated

2012-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

clarithromycin, sibutramine, clopidogrel

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.

Interventions

DRUGSibutramine-clopidogrel

Sibutramine-clopidogrel

DRUGsibutramine-Clarithromycin

sibutramine-Clarithromycin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* must be healthy volunteer

Exclusion criteria

* must not be under 18 years old

Design outcomes

Primary

Measure	Time frame	Description
effects of clopidogrel and clarithromycin on the disposition of sibutramine	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026