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

NCT01421706 | Completed Phase 1

• 1 other identifier: 08-073
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

clarithromycin; sibutramine; clopidogrel

Outcome Measures

Primary Outcomes (1)

• effects of clopidogrel and clarithromycin on the disposition of sibutramine

  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

Study Arms (2)

sibutramine-clopidogrel

ACTIVE COMPARATOR

sibutramine-clopidogrel

Drug: Sibutramine-clopidogrel

sibutramine-clarithromycin

ACTIVE COMPARATOR

sibutramine-clarithromycin

Drug: sibutramine-Clarithromycin

Interventions

Sibutramine-clopidogrel DRUG

Sibutramine-clopidogrel

sibutramine-clopidogrel

sibutramine-Clarithromycin DRUG

sibutramine-Clarithromycin

sibutramine-clarithromycin

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• must be healthy volunteer

You may not qualify if:

• must not be under 18 years old

Sponsors & Collaborators

• Inje University: lead

Study Officials

• JaeGook Shin, MD,PhD

  Inje University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 23, 2011
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 18, 2012

Record last verified: 2012-09