Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel

NCT ID: NCT01456546

Last Updated: 2013-07-03

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-07-31

Brief Summary

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The aim of this study is to investigate if the genetic variant CYP2C19\*17 affects the pharmacokinetics of proguanil and clopidogrel.

Detailed Description

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Conditions

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CYP2C19 Genotypes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Period A: proguanil

Proguanil pharmacokinetics

Group Type ACTIVE_COMPARATOR

Proguanil

Intervention Type DRUG

2x350 mg Malarone followed by 3 days of blood- and urine sampling

Period B: clopidogrel

Clopidogrel pharmacokinetics

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

2x300 mg Plavix followed by 7 hours days of blood sampling

Interventions

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Proguanil

2x350 mg Malarone followed by 3 days of blood- and urine sampling

Intervention Type DRUG

Clopidogrel

2x300 mg Plavix followed by 7 hours days of blood sampling

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* Written consent
* Age 18-65
* CYP2C19\*1 and or CYP2C19\*17 genotype.

Exclusion Criteria

* Daily medication
* Alcohol abuse
* Pregnancy
* Breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Rasmus Steen Pedersen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Pharmacology, University of Southern Denmark

Odense, Fyn, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AKF-380

Identifier Type: -

Identifier Source: org_study_id

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