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

September 16, 2012 updated by: Jae-Gook Shin, Inje University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • must be healthy volunteer

Exclusion Criteria:

  • must not be under 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sibutramine-clopidogrel
Drug: Sibutramine-clopidogrel
Sibutramine-clopidogrel
Active Comparator: sibutramine-clarithromycin
Drug: sibutramine-Clarithromycin
sibutramine-Clarithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 22, 2011

First Submitted That Met QC Criteria

August 22, 2011

First Posted (Estimate)

August 23, 2011

Study Record Updates

Last Update Posted (Estimate)

September 18, 2012

Last Update Submitted That Met QC Criteria

September 16, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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