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

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.

Timeline

Start

2005-02

Primary completion

—

Completion

2005-07

Drugs

Indications

No indication recorded.