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

UMIN ID: C000000003

Registered date:02/06/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Japanese healthy male volunteers
• Date of first enrollment: 2005/01/01
• Target sample size: 8
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Diphenhydramine 50mg single oral dose group
Matched placebo group

Outcome(s)

• Primary Outcome: Saccadic eye movement peak velocity
• Secondary Outcome: Other saccadic eve movement parameters (latency, inaccuracy) Visual analogue scale alertness score Plasma concentration of diphenhydramine

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 40years-old
• Gender: Male
• Exclude 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.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

Related Information

• Primary Sponsor: Showa University School of Medicine Second department of Pharmacology
• Secondary Sponsor: Yakusen-kai Kannondai Clinic
• Source(s) of Monetary Support: The Special Subsidies in Subsidies for ordinary expenses of private schools from the Ministry of Education, Culture, Sports, Science and Technology in 2005.,Not applicable