Randomized, double blind, crossover clinical pharmacological study to evaluate the relationships between dose-, concentration in blood-, and sedative effect after histamine H1 receptor antagonist d-chlorpheniramine intake using saccadic eye movement analysis in healthy male volunteers

UMIN ID: UMIN000000859

Registered date:20/10/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy male volunteers
• Date of first enrollment: 2007/10/01
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

d-Chlorpheniramine maleate 1 mg single oral dose
d-Chlorpheniramine maleate 2 mg single oral dose
d-Chlorpheniramine maleate 4 mg single oral dose

Outcome(s)

• Primary Outcome: Saccadic eye movement peak velocity
• Secondary Outcome: Visual analogue scale Plasma concrntration of chlorpheniramine

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male
• Exclude criteria: 1. Inappropriate clinical history for medication study (i.e. drug abuse, alcoholism, diseases of heart, liver, kidney, lung, and blood etc.) or who are ambulatory patients suffering theses diseases. 2. Subjects who are ingested medicine with sedatives or antihistaminic agents during this study. 3. Smoker 4. Any history for drug allergy. 5. Severe alcoholism. 6. Subjects who are inadequate for enrollment judged by the investigator.

Related Information

• Primary Sponsor: Showa University School of Pharmaceutical Sciences Department of Clinical Pharmacy
• Secondary Sponsor: Tsukuba Clinical Pharmacology Center Kan-nondai Clinic Showa University School of Medicine Second Department of Pharmacology
• Source(s) of Monetary Support: Grant-in Aid for Young Scientists (B)