The primary objective of this study is to measure and compare the acute effects of rupatadine 10 mg, relative to placebo and hydroxyzine 50 mg as an active control on healthy volunteers’ performance on a standard over-the-road driving test and a car-following test.

Condition	Intervention	Phase
Healthy	Drug: Rupatadine  Drug: Hydroxyzine  Drug: Placebo	Phase IV

Further Study Details: 

Primary Outcomes: Actual driving performance
Secondary Outcomes: Daytime sleepiness; Subjective sleepiness; Alertness
Expected Total Enrollment:  20

The study shall be conducted according to a three-way, double-blind, placebo and active controlled crossover design. Treatment groups are identified as follows.

• Rupatadine
• Hydroxyzine
• Placebo

Ages Eligible for Study:  21 Years   -   35 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

1. Normal healthy males or females
2. Subjects must be experienced drivers.
3. Vision: normal binocular acuity, corrected, or uncorrected.

Exclusion Criteria:

1. Pregnant or nursing females.

Please refer to this study by ClinicalTrials.gov identifier  NCT00162786

Erik Vuurman, PhD      +31 433881046    e.vuurman@np.unimaas.nl

Netherlands
      Brain and Behaviour Institute, Maastricht,  6229 ET,  Netherlands; Recruiting

Study chairs or principal investigators

Erik Vuurman, PhD,  Principal Investigator,  Maastricht University, Brain and Behaviour Institute   

Study ID Numbers:  DM02RUP/IV/04
Last Updated:  September 12, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00162786
Health Authority: The Netherlands: Dutch Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13