allergic rhinoconjunctivitis allergies hives urticaria
Conditions
Interventions
Intervention: In a crossover design all subjects will receive bilastine 20 mg,
hydroxyzine 50 mg, and placebo on three respective treatment days. There will
be at least a seven-day washout between e
Sponsors
TNO
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - All subjects must be normal healthy (non-smoking) males ages 18-40 of any race.;- Negative urine screen for drugs with a high potential for abuse.;- Subjects must be free of any clinically significant disease which would interfere with the study evaluations or study treatments.;- Subjects must have an ECG -QTc time within normal limits ;- Body Mass Index must be between 19 and 30 kg/m2;- Subjects must be willing to give written informed consent and must be able to adhere to dosing and visit schedules and meet study requirements.;- Adequate adaptation towards the differences in cabin pressure
Exclusion criteria
Exclusion criteria: - Subjects who have clinically significant abnormal physical findings or vital signs which could interfere with the objectives of the study. This includes subjects who have any history or symptoms of chronic illness, history of psychotic disorders, drug addiction or abuse of drugs or alcohol, or impaired mentation which could interfere with the completion of the study.;- Subjects requiring any CNS medication, or medication with sedative effects. ;- Subjects who have taken macrolide Antibiotics, antifungals, cimetidine, ranitidine within 7 days before the study;- Use of (non) prescription medications within the last 14 days, with the exception of aspirin and paracetamol up to 48 hours prior to the start of the study;- alcohol consumption of more than 21 units per week; ca*eine consumption of more than 6 cups per day; regular drinking of citric or grapefruit juice; treatment by atropine or atropine-like drugs;- Subjects with a history of allergies to more than two classes of medication or who are allergic to or cannot tolerate antihistamines.;- Subjects who have had an upper respiratory tract or sinus infection or who have had a viral upper respiratory infection within 7 days prior to Screening.;- Subjects with active seasonal and/or perennial allergic rhinitis.;- Subjects with urticaria;- The investigational study staff involved with this study.;- Subjects who have taken a sedative/hypnotic, antihistaminic or anticholinergic drugs during the three weeks prior to entering the first treatment phase.;- Subjects who have consumed alcoholic beverages within the last 24 hours prior to the start of the study or during the treatment study days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints:1) Vigilance &Tracking Test (VigTrack): root mean square of tracking error, percentage omissions, number of false reactions; 2) Multi-Attribute Task Battery (MAT): a) Monitoring performance: number of false reactions, number of omissions, mean response time; b) Tracking performance: root mean square of tracking error; c) Resource management: mean absolute deviation from target; 3) Stanford Sleepiness Scale (SSS): SSS-scores. | — |
Countries
Netherlands
Outcome results
None listed