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Most antihistamines are assumed to possess a more or less pronounced sedative potential in addition to their antihistaminic properties. Therefore, a single-blind three-way crossover study was designed to assess the influence of single-dose dimethindene maleate (new "once a day formulation") on vigilance and performance vs. loratadine as reference and vs. placebo. Drug effects on performance were tested in 18 healthy volunteers by the oculodynamic test [ODT, i.e. choice reaction task (CRT), combined with recording of electrooculography (EOG) and cardiovascular parameters] and effects on subjective well-being by visual analogue scales (VAS). Main target parameters for evaluation of CNS-effects are latency and subjective perception of sedation (VAS). Neither statistically significant nor clinically relevant differences in all objective and subjective target variables (ODT and VAS) between active drugs and placebo, after single-dose administration were found. The same holds for accessory EOG, CRT and vital parameters under workload.

UNCLASSIFIEDApproved for public release; distribution unlimited. • This report summarizes the results of Phase I of a study on the fea jbility .-V.and development of a standardized task battery for measiiement of human performance. Phase I includes literature reviews on task batteries, interviews with experts in the field of human performance and analytic studies of the theoretical background of existing and possible task batteries. Recormendations for a further task battery are given.

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