Randomized, placebo-controlled, single blind, crossover clinical study to evaluate the relationship between subjective sedation after a single dose of ebastine and gene polymorphisms in pharmacodynamics and pharmacokinetics of ebastine. The healthy Japanese volunteers had experience with subjective sedation after taking the second generation histamine H1 receptor antagonists.
Not Applicable
- Conditions
- Japanese healthy volunteers who had experience with subjective sedation after taking the second generation of histamine H1 receptor antagonist.
- Registration Number
- JPRN-UMIN000000567
- Lead Sponsor
- Showa University School of Pharmaceutical Sciences Department of Clinical Pharmacy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency distribution for MDR1, BCRP, CYP3A4, CYP2J2, CYP4F12 and HRH1 genotypes are evaluated in each group of subjective sedation scored by alertness score of VAS.
- Secondary Outcome Measures
Name Time Method Alertness score of VAS, the number of words typed and the number of mistyped characters are evaluated in each group of genotype.