UMIN ID: UMIN000000567
Registered date:01/03/2007
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.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Japanese healthy volunteers who had experience with subjective sedation after taking the second generation of histamine H1 receptor antagonist. |
| Date of first enrollment | 2007/03/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Ebastine 10mg single oral dose group Matched placebo group |
Outcome(s)
| Primary Outcome | 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 | Alertness score of VAS, the number of words typed and the number of mistyped characters are evaluated in each group of genotype. |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 45years-old |
| Gender | Male and Female |
| Include criteria | |
| 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 | Showa University School of Medicine Second Department of Pharmacology |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Noriko KOHYAMA PhD. |
| Address | 1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555 Japan |
| Telephone | 03-3784-8221 |
| noriko-kyb@pharm.showa-u.ac.jp | |
| Affiliation | Showa University School of Pharmaceutical Sciences Department of Clinical Pharmacy |
| scientific contact | |
| Name | Toshinori YAMAMOTO PhD. |
| Address | 1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555 Japan |
| Telephone | 03-3784-8221 |
| Affiliation | Showa University School of Pharmaceutical Sciences Department of Clinical Pharmacy |