Adult healthy male and female non-smokers
Conditions
Interventions
Group 1: Volunteers receive a low dose of iohexol (259 mg) in fasted state
Group 2: Volunteers receive a high dose of iohexol (3235 mg) in fasted state
Group 3: Volunteers receive a high dose of iohex
Sponsors
Institut I für Pharmakologie des Universitätsklinikums Köln (AöR)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Standard criteria for healthy individuals, non-smoker
Exclusion criteria
Exclusion criteria: Subjects with contraindications for iohexol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pharmacokinetic parameters of iohexol: CL; ratio of CL between the low and the high dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Further pharmacokinetic parameters of iohexol and creatinine as generated by the population pharmacokinetic evaluation Safety and Tolerability: • Medical history, AEs and well-being • Laboratory screen (haematology, clinical chemistry, urinalysis and TSH) • Alcohol breath test, drug screening, pregnancy tests (females only) • Physical examination • Vital functions: BP, PR and body temperature • 12-lead ECG | — |
Countries
Germany
Contacts
Public ContactUwe Fuhr
Institut I für Pharmakologie des Universitätsklinikums Köln (AöR)
Outcome results
None listed