Assessing a low iohexol dose as a marker of glomerular filtration rate in healthy volunteers
Not Applicable
- Conditions
- Adult healthy male and female non-smokers
- Registration Number
- DRKS00029908
- Lead Sponsor
- Institut I für Pharmakologie des Universitätsklinikums Köln (AöR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
Standard criteria for healthy individuals, non-smoker
Exclusion Criteria
Subjects with contraindications for iohexol
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main pharmacokinetic parameters of iohexol: CL; ratio of CL between the low and the high dose
- Secondary Outcome Measures
Name Time Method Further pharmacokinetic parameters of iohexol and creatinine as generated by the population pharmacokinetic evaluation<br><br>Safety and Tolerability:<br>•Medical history, AEs and well-being<br>•Laboratory screen (haematology, clinical chemistry, urinalysis and TSH)<br>•Alcohol breath test, drug screening, pregnancy tests (females only)<br>•Physical examination<br>•Vital functions: BP, PR and body temperature<br>•12-lead ECG