Placebo control, double blind, crossover clinical pharmacological study to evaluate a sedative effect after histamine H1 receptor antagonist diphenhydramine administration by using saccadic eye movement analyzing system and visual analogue scale (VAS) in healthy Japanese male volunteers - Clinical pharmacological study to evaluate a sedative effect of histamine H1 receptor antagonist diphenhyramine

The pharmacokinetics parameters of diphenhydramine in this study were similar to those reported previously. Values of Saccadic Peak Velocity (SPV), as a subjective parameter of sedative effect, and also values of sedative score of Visual Analogue Scale (VAS) in the Drewell group from 30 minutes to 180 minutes after drug administration declined significantly (p<0.05 paired t-test followed by repeated measures ANOVA). There was no significant difference in Latency and in Inaccuracy. SPV decreased with increasing plasma diphenhydramine concentration, and SPV recovered to baseline value with decreasing plasma diphenhydramine concentration. But there was a subject whose SPV change was not related to blood concentration levels. Jpn. J Clin. Pharmacol. Ther., 36(Suppl): S243, 2005 Jpn. J Clin. Pharmacol. Ther., 37(1): 55-64, 2006