Pharmacodynamic interactions of a solid formulation of sodium oxybate and ethanol in healthy volunteers.

ABSTRACT:

Aim

The pharmacologic effects of sodium oxybate (SO) have a number of similarities with those of alcohol. This study evaluated the pharmacodynamic interaction of SMO.IR (a solid immediate release formulation of SO) and alcohol (0.7 (males) or 0.57 (females) g kg(-1) alcohol using 40% vodka).

Methods

In a randomized, double-blind, double-dummy, crossover trial, 24 healthy volunteers received randomly a) 2.25 g SMO.IR and placebo alcohol preparation, b) 2.25 g f SMO.IR and alcohol, c) 2.25 g SMO.IR matching placebo and alcohol and d) 2.25 g of SMO.IR matching placebo and placebo alcohol preparation. Objective and subjective cognitive parameters, adverse events and vital signs were assessed before, 15 and 165 min after treatment administration.

Results

Alcohol produced t

SUBMITTER: Pross N 

PROVIDER: S-EPMC4574833 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature