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

University of Southern Denmark (SDU)

Status and phase: Completed; Phase 1

Conditions: CYP2C19 Genotypes

Treatments: Drug: Proguanil; Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01456546

AKF-380

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Daily medication
• Alcohol abuse
• Pregnancy
• Breastfeeding

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Period A: proguanil

Active Comparator group

Description:

Proguanil pharmacokinetics

Treatment:

Drug: Proguanil

Period B: clopidogrel

Active Comparator group

Description:

Clopidogrel pharmacokinetics

Treatment:

Drug: Clopidogrel