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

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 - Evaluation of the sedative effect of histamine H1 receptor antagonist by eye movement analyzing system

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000859

Enrollment

Registered

2007-10-20

Start date

2007-10-01

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

Healthy male volunteers

Interventions

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

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy male volunteer 2. Subjects are competent to consent, keep the rules of the study and are able to report self condition 3.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
Saccadic eye movement peak velocity	—

Secondary

Measure	Time frame
Visual analogue scale Plasma concrntration of chlorpheniramine	—

Countries

Japan

Contacts

Public ContactNoriko KOHYAMA PhD.

Showa University School of Pharmaceutical Sciences 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