European Journal of Clinical Pharmacology

, Volume 37, Issue 2, pp 193–194 | Cite as

Effect of urapidil on steady-state serum digoxin concentration in healthy subjects

  • P. Solleder
  • R. Haerlin
  • W. Wurst
  • I. Klingmann
  • H. Mosberg
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Summary

In an open, randomized, two-period change-over study the effect of urapidil, an antihypertensive agent, on steady-state serum digoxin levels was investgated in 12 healthy male volunteers. The subjects were given digoxin 0.25 mg once daily for 4 days to produce a steady-state digoxin level in serum. At the end of that time the subjects received either digoxin monotherapy or digoxin and concomitant treatment with urapidil 60 mg b.d. for a further 4 days. Subsequently the treatments were changed over.

The absorption characteristics Cmax and tmax of digoxin were not altered by concomitant urapidil treatment. The geometric mean and nonparametric 95% confidence limits of digoxin relative bioavailability were 97% (93%–103%).

Therefore, concomitant administration of urapidil with digoxin treatments did not appear to alter the rate and extent of absorption of the glycoside.

Key words

urapidil digoxin blood drug level pharmacokinetics drug absorption/-interaction 

References

  1. 1.
    Amery A (1986) Treatment of hypertension with urapidil. Preclinical and clinical update. Royal Society of Medicine Services, London (International Congress and Symposium Series)Google Scholar
  2. 2.
    Gillis RA, Kellar KJ, Quest JA, Manath IJ, Martino-Barrows A, Hill K, Gatti PJ, Dretchen K (1988) Experimental studies on the neurovascular effects of urapidil. Drugs 35 [Suppl 6]: 20–33Google Scholar
  3. 3.
    Nieder M, Dilger C, Haerlin R (1985) Quantitation of urapidil and its metabolites in human serum by high performance liquid chromatography. J High Res Chromatogr Commun 8: 224–229Google Scholar
  4. 4.
    Buck W (1975) Der Vorzeichen-Rang-Test nach Pratt. Methods Inf Med 14: 224–230Google Scholar
  5. 5.
    Steinijans VW, Diletti E (1983) Statistical analysis of bioavailability studies: parametric and nonparametric confidence intervals. Eur J Clin Pharmacol 24: 127–136Google Scholar
  6. 6.
    Westlake WJ (1979) Statistical aspects of comparative bioavailability trials. Biometrics 35: 237–280Google Scholar
  7. 7.
    Kirsten R, Nelson K, Steinijans VW, Zech K, Haerlin R (1988) Clinical pharmacokinetics of urapidil. Clin Pharmacokinet 14: 129–140Google Scholar

Copyright information

© Springer-Verlag 1989

Authors and Affiliations

  • P. Solleder
    • 1
  • R. Haerlin
    • 1
  • W. Wurst
    • 1
  • I. Klingmann
    • 2
  • H. Mosberg
    • 2
  1. 1.Byk Gulden PharmaceuticalsKonstanzFederal Republik of Germany
  2. 2.L.A.B. GmbH & CoUlmFederal Republik of Germany

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