Healthy male subjects
Conditions
Interventions
fexofenadine
olopatadine
ketotifen fumarate
placebo
Sponsors
Clinical trial Center,Kitasato University East Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Those who have the ability to provide written informed consent to participate in the study. - Healthy males aged between 20 and 40 years. - Body weight between 50 and 100 kg, and a body mass index (BMI) between 18 and 32 kg/m2.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleepiness | — |
Countries
Japan
Outcome results
None listed