Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance

Uriach

Status and phase: Terminated; Phase 4

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Hydroxyzine; Drug: Rupatadine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162786

DM02RUP/IV/04

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 21 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind