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
- Conditions
- Japanese healthy male volunteers
- Registration Number
- JPRN-C000000003
- Lead Sponsor
- Showa University School of Medicine Second department of Pharmacology
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 8
Not provided
1.Any clinically significant history of drug abuse, alcoholic abuse, heart, liver, kidney, lung, and blood disease etc. thought to be not eligible to participate in the study 2.Subjects known to treated with medicine which has a sedative effect or an antihistaminic agents 3.Subjects who can not abstaine from smoking during study period 4.Any drug allergy history 5.Subjects who is using excessive alcohol regularly (cannot keep abstinence for study period) 6.Perticipation in any clinical trial within 3 months 7.Donation of more than 200mL blood within 3 months 8.Any use of drugs in the 2 weeks prior to study drug administration 9.Subjects who, in the opinion of the investigator, are not likely to participate in the study for any reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Saccadic eye movement peak velocity
- Secondary Outcome Measures
Name Time Method Other saccadic eve movement parameters (latency, inaccuracy) Visual analogue scale alertness score Plasma concentration of diphenhydramine