Single dose pharmacokinetics of fenspiride hydrochloride: phase I clinical trial.
The absolute bioavailability of fenspiride has been studied in twelve healthy volunteers. It was administered IV and orally in single doses of 80 mg fenspiride hydrochloride according to a randomised crossover pattern. Following IV administration, the plasma clearance of fenspiride was about 184 ml.min-1, and its apparent volume of distribution was moderately large (215 l). When given orally as a tablet, fenspiride exhibited fairly slow ab- sorption; the maximum plasma concentration (206 ng.ml-1) was achieved 6 h after administration. The absolute bioavailability was almost complete (90%). The tablet had slow release characteristics. The elimination half-life obtained from the plasma data was 14 to 16 h independent of the route of administration.
Montes
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B
Servicio de Farmacologia Clinica, Universidad de Navarra, Pampelona, Spain.
Catalan
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M
Roces
A
A
Jeanniot
J P
JP
Honorato
J M
JM
D000284:Administration, Oral; D000328:Adult; D001682:Biological Availability; D001794:Blood Pressure / Q000187:drug effects; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D013141:Spiro Compounds / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000494:pharmacology
D013141:Spiro Compounds