The objectives of this trial are not related in any way to assess safety or efficacy of intravenous or oral ethanol, it aims to develop a pharmacokinetic model to assess inter-individual variability.
Conditions
Interventions
Group 1: Patients with high oral administration rate of ethanol with a bolus dose of 0.7g/kg BW (0.35g/kg BW in Asians and patients older than 65 years respectively)
Group 2: Patients with low oral ad
7 fractions will be taken in 10 min intervals
Group 3: Patients with intravenous administration of ethanol with an infusion of 0.5g/kg BW (0.25g/kg BW in Asians respectively)
50 g ethanol (Alkohol-Konzentrat 95 % Braun) will be dissolved in 1L 5% glucose solution and the appropriate volume is administered over 1 hour
Sponsors
Institut I für Pharmakologie, Universitätsklinikum Köln (AöR)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Willingness and capability to confirm written consent to enrolment and having given written informed consent after ample information has been provided.
Exclusion criteria
Exclusion criteria: Standard exclusion criteria for studies in healthy volunteers under 65 years; ASA III or higher for volunteers over 65 years and conditions or medications that preclude alcohol intake; History or presence of ethanol addiction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of ethanol and its metabolites | — |
Secondary
| Measure | Time frame |
|---|---|
| Known individual covariates (e.g. sex, age, ethnic group) | — |
Countries
Germany
Contacts
Public ContactUwe Fuhr
Institut I für Pharmakologie, Universitätsklinikum Köln (AöR)
Outcome results
None listed