A double-blind cross-over study comparing the effects of single doses of fexofenadine, olopatadine, ketotifen fumarate and placebo on sedation in healthy Japanese subjects

Not Applicable

• Conditions: Healthy male subjects

• Registration Number: JPRN-UMIN000008406
• Lead Sponsor: Clinical trial Center,Kitasato University East Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

-Any anaphylaxis with fexofenadine, olopatadine or ketotifen fumarate. -Any renal or hepatic disease requiring treatment. -Any convulsive disease or disease requiring treatment. -Any hereditary problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. -QT prolongation over 460 ms. -Use of any medicine or health product that contains Saint John's wort within 7 days before dosing. - Intake of fruit juice containing grapefruit juice or orange juice within 7 days before dosing. - Participation in any other clinical reseach in the past 3 months. - Donating over 200 ml of blood within the past 1 month or over 400 ml of blood within the past 3 months. - Poorly controlled arterial hypertension (Systolic blood pressure >160mmHg and/or diastolic blood pressure >100mmHg) - Positive HIV antibody, VDRL(quality), HBs antigen or HCV antibody. - Positive drug screening. - Any condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleepiness