Official Title: “Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety Study

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

Intervention(s) in this Clinical Trial

• Drug: Rupatadine
• Drug: Hydroxyzine
• Drug: Placebo

Primary Measures

• Actual driving performance

Secondary Measures

• Daytime sleepiness
• Subjective sleepiness
• Alertness

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: J. Uriach and Company

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00162786

Study ID Number: DM02RUP/IV/04

ClinicalTrials.gov Identifier: NCT00162786

Health Authority: Netherlands: Medical Ethics Review Committee (METC)