Randomized, double blind, crossover clinical study to evaluate the sedative effect after the treatment of 1 mg dose of ketotifen, or 10 or 20 mg dose of cetirizine using saccadic eye movement analysis in healthy male volunteers

Randomized, double blind, crossover clinical study to evaluate the sedative effect after the treatment of 1 mg dose of ketotifen, or 10 or 20 mg dose of cetirizine using saccadic eye movement analysis in healthy male volunteers - Evaluation of the sedative effect by ketotifen or cetirizine treatment using saccadic eye movement analysis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004527

Enrollment

Registered

2010-11-09

Start date

2010-11-01

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

allergic rhinitis, pollen allergy

Interventions

Single dose of Ketotifen (1 mg) by oral route Single dose of Cetirizine (10 mg) by oral route Single dose of Cetirizine (20 mg) by oral route

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy volunteers enrolled this study must be agreement with the following criteria: 1.Age between 20 and 35 2.Male 3.Subjects are competent to consent, keep the rule of this 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.Subjects who have inappropriate medical history (ex., drug abuse, alcoholism, any kind of heart, liver, kidney, lung, eye and blood diseases etc.) or who are ingested medicine during this study. 2.Smoker. 3.Any drug allergy. 4.Subjects who are using excessive alcohol regularly (cannot keep abstinence for study period) 5.Nocturnal habits during night. 6.Participation in any clinical trial within the last 3 months. 7.Subjects who are inadequate for enrollment judged by the investigators.

Design outcomes

Primary

Measure	Time frame
Saccadic peak velocity	—

Secondary

Measure	Time frame
Latency Inaccuracy Visual Analogue Scale	—

Countries

Japan

Contacts

Public ContactNoriko KOHYAMA

School of Pharmacy, Showa University Department of Clinical Pharmacy

noriko-kyb@pharm.showa-u.ac.jp

Outcome results

None listed

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