Between-subject and within-subject variations in the pharmacokinetics of ethanol.

1. Twelve healthy men drank 0.80 g ethanol kg-1 body weight on four occasions spread over several weeks. Ethanol was given as 96% v/v solvent which was diluted with orange juice to make a cocktail (20-25% v/v). This drink was ingested in exactly 30 min at 08.00 h after an overnight (10 h) fast. 2. Samples of venous blood were obtained at exactly timed intervals of 0, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 min after the start of drinking. The concentrations of ethanol in whole blood were determined by headspace gas chromatography. 3. Summary measures were used to evaluate the concentration-time profiles of ethanol for each subject. The between-subject and within-subject components of variation for the pharmacokinetics of ethanol were derived by one-way analysis of variance (ANOVA). 4. The variation between different subjects dominated the total variance for all of the pharmacokinetic parameters studied except the rate of disappearance of ethanol from blood (ko). For this latter parameter, 42% and 58% of the total variation arose from variations between- and within-subjects respectively. These results might be important to consider when experiments on the clinical pharmacokinetics of ethanol are being planned.

RCT Entities:   Population Interventions Outcomes