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Evaluation of Possible Effects on the QT/ QTc Interval of Rupatadine in Healthy Volunteers

NCT00199225 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2005-12-15

No results posted yet for this study

Summary

This phase I trial will evaluate the effects of rupatadine, at a dose of 10 mg OD (authorised and marketed dose) and the 100mg/day (supratherapeutic dose) on the ECG parameters with a special focus on its effect on cardiac repolarisation (QTc interval duration).Furthermore, the study is performed to assess the pharmacokinetic-pharmacodynamic relationship between plasma concentration of rupatadine and its effects, if any, on cardiac repolarisation mainly in the QTc interval).

The main objective is to assess whether administration of a repeated dose of 10 and 100 mg/day , has the potential to cause QT prolongation in healthy volunteers.

Conditions

  • Human Experimentation (Human Volunteers)

Interventions

DRUG

Rupatadine

DRUG

moxifloxacin

PROCEDURE

Continous electrocardiographic register

PROCEDURE

Pharmacokinetic profile

Sponsors & Collaborators

  • J. Uriach and Company

    lead INDUSTRY

Principal Investigators

  • Manuel Barbanoj, MD · Institut de Recerca-Hospital de la Santa Creu i Sant Pau

  • Rosa Mª Antonijoan, MD · Institut de Recerca- Hospital de la Santa Creu i Sant Pau

  • Esther G Donado, PhD · J. Uriach and Company

  • Iñaki Izquierdo, MD · J. Uriach and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Completion
2005-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00199225 on ClinicalTrials.gov