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

NCT ID: NCT01421706

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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sibutramine-clopidogrel

sibutramine-clopidogrel

Group Type ACTIVE_COMPARATOR

Sibutramine-clopidogrel

Intervention Type DRUG

Sibutramine-clopidogrel

sibutramine-clarithromycin

sibutramine-clarithromycin

Group Type ACTIVE_COMPARATOR

sibutramine-Clarithromycin

Intervention Type DRUG

sibutramine-Clarithromycin

Interventions

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Sibutramine-clopidogrel

Sibutramine-clopidogrel

Intervention Type DRUG

sibutramine-Clarithromycin

sibutramine-Clarithromycin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* must be healthy volunteer

Exclusion Criteria

* must not be under 18 years old
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Jae-Gook Shin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JaeGook Shin, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Other Identifiers

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08-073

Identifier Type: -

Identifier Source: org_study_id

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