ECG Studies with Astemizole

Author:

Craft T.M.1,Vanden Bussche G.2,De Cree J.3,Griffiths J.V.4

Affiliation:

1. Department of Anaesthesia and Intensive Care, Milton Keynes, Bucks, UK

2. Janssen Pharmaceutica nv, Beerse, Belgium

3. Clinical Research Unit, St. Bartholomeus, Jan Palfijn Hospital IB-2060 Merksem, Belgium

4. Janssen Pharmaceutical Limited, Grove, Wantage, Oxfordshire, UK

Abstract

1 Six healthy volunteers took part in a 2-week haemodynamic safety study of astemizole. 2 They were given 30 mg daily (3 x 10 mg tablets) for the first 3 days and 10 mg daily for the next 12 consecutive days. 3 Heart rate, blood pressure, ECG and systolic time intervals at rest were measured before the start and five times during the day. 4 No changes were observed in any of the parameters measured. The configuration of the ECG was not influenced. 5 Serum concentrations of astemizole plus hydroxylated metabolites measured at the end of the study were 16 times lower than those detected in a patient overdosing on 200 mg astemizole.

Publisher

SAGE Publications

Subject

Health, Toxicology and Mutagenesis,Toxicology

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