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Human & Experimental Toxicology
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ECG Studies with Astemizole

T.M. Craft

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

G. Vanden Bussche

Janssen Pharmaceutica nv, Beerse, Belgium

J. De Cree

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

J.V. Griffiths

Janssen Pharmaceutical Limited, Grove, Wantage, Oxfordshire, UK

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.

Human & Experimental Toxicology, Vol. 6, No. 6, 527-528 (1987)
DOI: 10.1177/096032718700600614


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