Allergy (Healthy volunteers)
Conditions
Interventions
levocetirizine 5mg
fexofenadine 60mg
diphenhydramine 50mg
placebo
Sponsors
Tohoku University Cyclotron and Radioisotope Center
Tohoku University Graduate School of Medicine, Department of Pharmacology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy volunteers with his/her own will and without any subordinate relation. 2) Healthy volunteers (men and women; young subgroup ranging 20-40 years old and elderly subgroup ranging 65-79 years old) who understand the purpose of this study well. 3) Healthy volunteers who have driving habit of at least once a week for more than 1 year. 4) Subjects who can take enough sleep and rest during the night before the clinical test. 5) Subjects who can read documents attached to e-mails. 6) Subjects who can contact by mobile phones and who can participate 4 serial clinical tests.
Exclusion criteria
Exclusion criteria: Subjects with the following conditions are to be excluded: 1) Subjects who take medication acting on histaminergic nervous systems including antihistamines 2) Women being possiblly pregnant 3) Subjects with past history of severe epilepsy and allergic reactions 5) Subjects with moderate to severe glaucoma and uninary tract obstruction such as prostatic enlargement 6) Subjects with other disorders to which administration of anticholinergic and antihistaminergic treatment is not suitable 7) Subjects with moderate to severe abnormality in renal and liver functions 8) Subjects with moderate to severe cognitive impairment 9) Subjects with other abnormalities, the investigators think the inclusion to this study is not suitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performances in simulated car-driving tests done before and after oral administration of levocetirizine 5 mg, fexofenadine 60 mg, diphenhydramine 50mg and placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective sleepiness scale and time course of plasma drug concentration measureed before and after oral administration of levocetirizine 5 mg, fexofenadine 60 mg, diphenhydramine 50mg and placebo. | — |
Countries
Japan
Contacts
Public ContactManabu TASHIRO
Tohoku University Cyclotron and Radioisotope Center Division of Cyclotron Nulclear Medicine (a branch clinic of Tohoku University Hospital)
Outcome results
None listed