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Sponsored by: |
J. Uriach and Company |
Information provided by: | J. Uriach and Company |
ClinicalTrials.gov Identifier: | NCT00162786 |
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 |
ChemIDplus related topics: | Hydroxyzine Hydroxyzine dihydrochloride Hydroxyzine pamoate |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety Study |
Official Title: | Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance |
Estimated Enrollment: | 20 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | November 2005 |
The study shall be conducted according to a three-way, double-blind, placebo and active controlled crossover design. Treatment groups are identified as follows.
Ages Eligible for Study: | 21 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
1. Pregnant or nursing females.
Netherlands | |||||
Brain and Behaviour Institute | |||||
Maastricht, Netherlands, 6229 ET |
J. Uriach and Company |
Principal Investigator: | Erik Vuurman, PhD | Maastricht University, Brain and Behaviour Institute |
Study ID Numbers: | DM02RUP/IV/04 |
First Received: | September 9, 2005 |
Last Updated: | October 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00162786 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
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