Characterisation of the drug-metabolising capacity of CYP2C19
Conditions
Interventions
Group 1: Open, randomised, single-dose pharmacokinetic study in cross-over design with administration of omeprazole 10 mg p.o. on one study day. The blood levels are determined over 33 hours in each c
Sponsors
Institut für klinische Pharmakologie
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: - healthy adults (age = 18 and < 60 years) - Presence of written informed consent - BMI between 18 and 30
Exclusion criteria
Exclusion criteria: - Hypersensitivity to one of the active ingredients or its components - Hypersensitivity to any component of the potato meal - Regular intake of medicines (exception: thyroid hormones, anti-allergic drugs, and antiasthmatic drugs) - Taking a PPI within the last week - Alcohol consumption within the last week - Cannabis use within the last week - Pregnancy and breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterisation of CYP2C19 enzyme by pantoprazol. Correlation of the interindividual variability of drug levels of pantoprazole compared to the drug omeprazole, which is established as a probe drug. Drug levels are determined in the blood at 15 time points. At the following time points, drug levels are analysed (each in minutes): 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 480, 1980 | — |
Secondary
| Measure | Time frame |
|---|---|
| Influence of drug plasma levels by possible influencing factors such as genotypes, sex, or diet. Determination of the activity of the enzyme CYP2D6 from food using solanidin, i.e. degradation products of potato, and its dependence on other influencing factors. | — |
Countries
Germany
Contacts
Public ContactKatja Just
Institut für klinische Pharmakologie
Outcome results
None listed