Kinetic and dynamic interaction of clobazam and alcohol.

Abstract

I The present study was designed to investigate both pharmacodynamic and pharmacokinetic interactions of clobazam and alcohol. 2 Eight healthy male volunteers participated in an intraindividual Latin square comparison of (a) clobazam 20 mg; (b) placebo; (c) alcohol + placebo; and (d) alcohol + clobazam 20 mg. Alcohol was administered orally in quantities individually calculated to yield serum alcohol concentrations of about 1000 gg/ml. The comparison of treatments (a) against (b) and (c) against (d) was double blind. Drug- free periods between the trials were 7 days. 3 Pharmacodynamic assessments were carried out before and 2, 3 and 5 h after administration using a series of tests of choice reaction performance, simple reaction time, two-hand coordination and body sway, together with self ratings, side-effects lists, vital signs and blood chemistry. 4 Blood samples were obtained before and 50, 100, 160, 220, 280, 340 and 1440 min after administration. Serum levels of clobazam and alcohol were determined by gas chromatography.