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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
ClinicalTrials.gov Identifier:
NCT01421706
First received: August 22, 2011
Last updated: September 16, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Sibutramine-clopidogrel
Drug: sibutramine-Clarithromycin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Inje University:

Primary Outcome Measures:
  • effects of clopidogrel and clarithromycin on the disposition of sibutramine [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sibutramine-clopidogrel
sibutramine-clopidogrel
 Drug: Sibutramine-clopidogrel
Sibutramine-clopidogrel
Other Name: Sibutramine-clopidogrel
Active Comparator: sibutramine-clarithromycin
sibutramine-clarithromycin
 Drug: sibutramine-Clarithromycin
sibutramine-Clarithromycin
Other Name: sibutramine-Clarithromycin

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

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • must be healthy volunteer

Exclusion Criteria:

  • must not be under 18 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421706

Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: JaeGook Shin, MD,PhD Inje University
  More Information

No publications provided

Responsible Party: Jae-Gook Shin, Professor, Inje University
ClinicalTrials.gov Identifier: NCT01421706     History of Changes
Other Study ID Numbers: 08-073
Study First Received: August 22, 2011
Last Updated: September 16, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Inje University:
clarithromycin
sibutramine
clopidogrel

Additional relevant MeSH terms:
Clarithromycin
Clopidogrel
Ticlopidine
Sibutramine
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents
Purinergic P2Y Receptor Antagonists
 Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013