Single dose pharmacokinetics of fenspiride hydrochloride: phase I clinical trial

Eur J Clin Pharmacol. 1993;45(2):169-72. doi: 10.1007/BF00315501.

Abstract

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Biological Availability
  • Blood Pressure / drug effects
  • Drug Administration Schedule
  • Drug Tolerance
  • Heart Rate / drug effects
  • Humans
  • Male
  • Metabolic Clearance Rate
  • Spiro Compounds / administration & dosage
  • Spiro Compounds / pharmacokinetics*
  • Spiro Compounds / pharmacology

Substances

  • Spiro Compounds