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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period A: proguanil | Active Comparator | Proguanil pharmacokinetics |
|
| Period B: clopidogrel | Active Comparator | Clopidogrel pharmacokinetics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proguanil | Drug | 2x350 mg Malarone followed by 3 days of blood- and urine sampling |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proguanil pharmacokinetics. Primary endpoint is cycloguanil formation clearance. | Based on blood- and urine-concentrations of proguanil and the metabolites cycloguanil and 4-chlorphenylbiguanid a comparison of the pharmacokinetic parameters (AUC, Cmax, Tmax, T1/2) between the three groups of genotypes (CYP2C19*1/*1, CYP2C19*1/*17 and CYP2C19*17/*17) will be made. | Hours after administration: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 10, 24, 31, 48, 55 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of the derivatised active clopidogrel metabolite. | Based on blood-concentrations of the derivatised active metabolite of clopidogrel a comparison of the pharmacokinetic parameters (AUC, Cmax, Tmax, T1/2) between the three groups of genotypes (CYP2C19*1/*1, CYP2C19*1/*17 and CYP2C19*17/*17) will be made. Secondly, a comparison of the platelet inhibitory of clopidogrel between the three groups of genotypes (CYP2C19*1/*1, CYP2C19*1/*17 and CYP2C19*17/*17) will be made using the VerifyNow® P2Y12 Test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology, University of Southern Denmark | Odense | Fyn | DK-5000 | Denmark |
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| ID | Term |
|---|---|
| D002727 | Proguanil |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D013988 |
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| Clopidogrel |
| Drug |
2x300 mg Plavix followed by 7 hours days of blood sampling |
|
| Hours after administration: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7 |
| Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |