A three-way crossover clinical pharmacological study to evaluate a drug interaction on P-gp at Blood Brain Barrier between histamine H1 receptor antagonist Ebastine and P-gp inhibitor Verapamil by using saccadic eye movement analyzing system and visual analogue scale (VAS) in healthy Japanese male volunteers

UMIN ID: UMIN000000577

Registered date:01/02/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: healthy Japanese male volunteers
• Date of first enrollment: 2007/01/01
• Target sample size: 8
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ebastin 10 mg single oral dose
Ebastin 20 mg single oral dose
Ebastin 10 mg single oral dose +Verapamil 80 mg single oral dose

Outcome(s)

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

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. Subjects who have the 1st deg. AV block on their ECG examination at screening visit. 5. Subjects who have any clinically significant abnormalities on their ECG examination at screening visit. 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 4 months 9.Donation of more than 200mL blood within 3 months 10.Any use of drugs in the 2 weeks prior to study drug administration 11.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 2006.,Not applicable