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European Journal of Clinical Pharmacology

, Volume 45, Issue 2, pp 169–172 | Cite as

Single dose pharmacokinetics of fenspiride hydrochloride: phase I clinical trial

  • B. Montes
  • M. Catalan
  • A. Roces
  • J. P. Jeanniot
  • J. M. Honorato
Originals

Summary

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 (2151).

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.

Key words

Fenspiride pharmacokinetics bioavailability 

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Copyright information

© Springer-Verlag 1993

Authors and Affiliations

  • B. Montes
    • 1
  • M. Catalan
    • 1
  • A. Roces
    • 2
  • J. P. Jeanniot
    • 3
  • J. M. Honorato
    • 1
  1. 1.Servicio de Farmacologia Clinica, Unidad de Fase I, Centro de Investigacion en Farmacologia AplicadaUniversidad de NavarraRampelonaSpain
  2. 2.Laboratorios ServierMadridSpain
  3. 3.Bio-Pharmacie ServierOrléansFrance

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