In vivo characterisation of cytochrome P450 enzyme by pantoprazole in healthy volunteers
Not Applicable
Recruiting
- Conditions
- Characterisation of the drug-metabolising capacity of CYP2C19
- Registration Number
- DRKS00031441
- Lead Sponsor
- Institut für klinische Pharmakologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
healthy adults (age = 18 and < 60 years)
- Presence of written informed consent
- BMI between 18 and 30
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Characterisation of CYP2C19 enzyme by pantoprazol.<br>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 Outcome Measures
Name Time Method Influence of drug plasma levels by possible influencing factors such as genotypes, sex, or diet.<br>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.