allergic rhinitis Sedation antihistamine Bilastine
Conditions
Interventions
1. Bilastine 20 mg
2. Bilastine 40 mg
3. Placebo
4. Active control: hydroxyzine.
Sponsors
FAES FARMA S.A.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged between 21 and 45 years; 2. Healthy volunteers; 3. BMI between 19 and 30; 4. Having a valid driving licence for more than 3 years; 5. Having a driving experience of at least 5000 km per year; 6. Able to give a written informed consent; 7. Able to understand the protocol and to come to the visits; 8. Use of a contraceptive method (for women).
Exclusion criteria
Exclusion criteria: 1. Medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, could jeopardize their health or is likely to modify their handling of the study drug; 2. Any non corrected visual defect or locomotor disorder which could interfere with the study; 3. Acute or chronic systemic disease or disorder; 4. History of hypersensitivity to H1 antihistamines, benzimidazoles or lactose; 5. Seasonal allergic rhinitis or urticaria treated by antihistamine; 6. History of alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standard deviation of the lateral position (SDLP) in the Road Tracking test on day 1 and 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Standard deviation of Speed (SDSP) in the Road tracking test on day 1 and 8; 2. Safety parameters: clinical signs and symptoms from physical examination, adverse evetns, laboratory safety, vital signs and ECGs. | — |
Contacts
Public ContactJ.G. Ramaekers
Maastricht University Dept of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience, P.O. Box 616
Outcome results
None listed