Placebo control, double blind, crossover clinical pharmacological study to evaluate a sedative effect after histamine H1 receptor antagonist diphenhydroamine (Drewell®) administration by using saccadic eye movement analyzing system in healthy Japanese elderly male volunteers.

Not Applicable

• Conditions: Japanese healthy elderly male volunteers

• Registration Number: JPRN-C000000274
• 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. The values of Saccadic Peak Velocity (SPV) and also Inaccuracy (IAC), as a subjective parameter of sedative effect in the Drewell group from 90 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 Visual Analogue Scale (VAS), as a subjective parameter for sedation. Jpn. J Clin. Pharmacol. Ther.,37(5), p283-290, 2006

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-12-01
• Study Start: 2006-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

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.Past history and/or present illness of glaucoma 4. Past history and/or present illness of prostatic hypertrophy or dysuria 5.Subjects who can not abstaine from smoking during study period 6.Any drug allergy history 7.Subjects who is using excessive alcohol regularly (cannot keep abstinence for study period) 8.Perticipation in any clinical trial within 3 months 9.Donation of more than 200mL blood within 3 months 10.Any use of drugs in the 1 weeks prior to study drug administration 11. Person who cannot do appropriate measurement according to the instruction at training session 12.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