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PHARMACOKINETICS AND SAFETY OF SINGLE INTRAVENOUS AND ORAL DOSES OF DOLASETRON MESYLATE IN HEALTHY WOMEN

✍ Scribed by ANTHER C. F. KEUNG; HÉLÈNE LANDRIAULT; MARC LEFEBVRE; DENIS GOSSARD; ELLEN E. DEMPSEY; MARTIN JUNEAU; DAN DIMMITT; MARK CASTLES; LISA ROBERTS; JEAN SPÉNARD

Publisher
John Wiley and Sons
Year
1997
Tongue
English
Weight
136 KB
Volume
18
Category
Article
ISSN
0142-2782

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✦ Synopsis

Twenty-four healthy women received 2´4 mg kg 71 dolasetron mesylate (1´8 mg kg 71 dolasetron base) by a 10 min intravenous administration and by oral administration. Pharmacokinetics of dolasetron and of its active reduced metabolite MDL 74 156 were monitored for 48 h in plasma. Urine was collected from 0 to 48 h, blood pressure and heart rate were measured at 0, 0´08, 1, 2, 12, 24, and 36 h, and ECGs were measured at 0, 0´08 (intravenous only), 1, 2, and 36 h after dosing. Dolasetron was widely distributed and rapidly reduced (mean t 1/2 =0´23 h) to MDL 74 156 (mean t 1/2 =8´05 and 9´12 h after intravenous and oral administration respectively). MDL 74 156 was extensively distributed; between 27 (oral route) and 33% (intravenous route) was eliminated unchanged in urine. Safety assessment showed mild to moderate headache, dizziness, and hot ¯ushes after the intravenous administration and headache, abdominal cramps or pain, and constipation after oral administration. Small and clinically non-signi®cant changes in PR, QRS, and QT c intervals were observed. We conclude that there is no obvious dierence in dolasetron pharmacokinetics between healthy women and men and that dolasetron can be used as safely in women as in men. &1997 by John Wiley & Sons, Ltd.

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