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European Journal of Clinical Pharmacology

, Volume 38, Issue 6, pp 629–631 | Cite as

Comparative bioavailability of a cisapride suppository and tablet formulation in healthy volunteers

  • T. Hedner
  • J. Hedner
  • A. Gelin-Friberg
  • M. L. Huang
  • S. Van de Poel
  • R. Woestenborghs
  • A. Van Peer
  • J. Heykants
Short Communications

Summary

The comparative bioavailability of cisapride as a 30 mg suppository and three 5 mg oral tablets was investigated in 12 non-smoking, healthy male volunteers. The two formulations were administered on two separate occasions following an overnight fast, according to a randomized cross-over design. The plasma concentration of cisapride was measured over 48 h after drug administration. The 30 mg suppository exhibited a mean time to the peak plasma concentration of 3.8 h, while the tablets showed a significantly earlier peak time of 1.5 h. The maximum plasma concentration of cisapride after the 30 mg suppository (50.3 ng · ml−1) was significantly lower than after the tablets (74.3 ng · ml−1). The AUCs following the two treatments did not differ significantly from each other.

The comparative bioavailability of the 30 mg cisapride suppository in relation to the three 5 mg oral tablets was 85%, with a 95%-confidence interval of 67% to 102% (not adjusted for dose). Normalizing the mean AUC by dose, the relative bioavailability of the suppository was 43% of that of the tablet. The elimination half-life of cisapride was not significantly different following the administration of the two formulations (9.3 h for the suppository and 9.8 h for the tablet).

Key words

Cisapride pharmacokinetics bioavailability suppository tablet 

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References

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Copyright information

© Springer-Verlag 1990

Authors and Affiliations

  • T. Hedner
    • 1
  • J. Hedner
    • 1
  • A. Gelin-Friberg
    • 2
  • M. L. Huang
    • 3
  • S. Van de Poel
    • 3
  • R. Woestenborghs
    • 3
  • A. Van Peer
    • 3
  • J. Heykants
    • 3
  1. 1.Department of Clinical PharmacologySahlgren's University HospitalSweden
  2. 2.Department of Clinical ResearchIanssen Pharma ABGöteborgSweden
  3. 3.Department of Drug Metabolism and PharmacokineticsJanssen Research FoundationBeerseBelgium

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