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

U

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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