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.

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. - Clinical study on sedative effect of histamine H1 receptor antagonist ebastine. -Study on gene polymorphisms associated with individual difference in subjective symptoms.-

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000567

Enrollment

Registered

2007-03-01

Start date

2007-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Japanese healthy volunteers who had experience with subjective sedation after taking the second generation of histamine H1 receptor antagonist.

Interventions

Ebastine 10mg single oral dose group Matched placebo group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers age from 20 to less than 45 years old. 2. Subjects who had experience with subjective sedation after taking the second generation of histamine H1 receptor antagonist by questionnaire survey. 3. Subjects are competent to consent, keep the rules of the study and are able to report self condition. 4. Subjects who are judged eligible by the investigator in several series of medical check.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Alertness score of VAS, the number of words typed and the number of mistyped characters are evaluated in each group of genotype.	—

Countries

Japan

Contacts

Public ContactNoriko KOHYAMA PhD.

Showa University School of Pharmaceutical Sciences Department of Clinical Pharmacy

noriko-kyb@pharm.showa-u.ac.jp03-3784-8221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026