Drug metabolism of healthy participants
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age 18-55 years Laboratory values in normal range: Elektrolytes (Na, K, Cl, Ca), Creatinin, Urea, Albumin, Hemoglobin, Hematokrit, INR <1.5 No severe pathologic findings in the cardiovascular, renal, pulmonal, hematopoetical, hepatic or neuronal system No acute pathology during screening Informed consent
Exclusion criteria
Exclusion criteria: Known hypersensitivity to the probe drug cocktail Laboratory values outside reference range (as judged by the investigator) Pregnancy Contraception with hormonal contraceptives Drug use within 3 days before phenotyping Expected non-compliance Other absolute and relative contraindications of the probe drugs Other conditions that might render the subject inappropriate for this trial (as judged by the investigator) Concurrent participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic ratios of probe drugs and their metabolites (Blood sample 5 hours after application of drug cocktail or during 8 hours after application as urine collection.) | — |
Secondary
| Measure | Time frame |
|---|---|
| Genome-wide association study of metabolic ratios | — |
Countries
Germany
Contacts
Institut für Experimentelle und Klinische Pharmakologie, UKSH, Campus Kiel