European Journal of Clinical Pharmacology

, Volume 30, Issue 3, pp 367–369 | Cite as

Effect of food on cibenzoline bioavailability

  • J. W. Massarella
  • H. P. Blumenthal
  • T. Silvestri
  • A. Lin
Short Communications


Eighteen healthy adult volunteers received 160 mg oral capsule doses of cibenzoline in an open-label, four-way randomized crossover study designed to determine the influence of food on cibenzoline pharmacokinetics. Cibenzoline was administered 1 h prior to, with, and 1 h following a standard breakfast as well as under fasting conditions. There was no change in any bioavailability parameter when the data following drug ingestion 1 h prior to food were compared to the fasted state. Bioavailability parameters obtained when drug was taken during the meal or 1 h after the meal suggested that the rate of absorption was slightly decreased in the presence of food, while the extent of absorption was unaltered. The decreased absorption rate in the presence of food is not expected to be of clinical significance. The presence of food is not expected to affect the bioavailability of cibenzoline to the extent of clinical significance.

Key words

cibenzoline bioavailability 


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  1. 1.
    Brazzell RK, Rees MMC, Khoo K-C, Szuna AJ, Sandor D, Hanigan JJ (1984) Age and cibenzoline disposition. Clin Pharmacol Ther 36: 613–619Google Scholar
  2. 2.
    Canal M, Flouvat B, Tremblay D, Dufour A (1983) Pharmacokinetics in man of a new antiarrhythmic drug, cibenzoline. Eur J Clin Pharmacol 24: 509–515Google Scholar
  3. 3.
    Colburn WA, Gibson DM, Wiens RE, Hanigan JJ (1983) Food increases the bioavailability of isotretinoin. J Clin Pharmacol 23: 534–539Google Scholar
  4. 4.
    Hackman MR, Lee TL, Brooks MA (1983) Determination of cibenzoline in plasma and urine by high performance liquid chromatography. J Chromatogr 273: 347–359Google Scholar
  5. 5.
    Hedayat A, Afsarinejad K (1978) Repeated measurements design II. Ann Stat 6: 616–629Google Scholar
  6. 6.
    Herpin D, Gaudean B, Bautand P, Amiel A, Tourdais B, Demange J (1981) Clinical trial of a new anti-arrhythmic drug: Cibenzoline (Cipralan). Clin Ther Res 30: 742–752Google Scholar
  7. 7.
    Khoo K-C, Szuna AJ, Colburn WA, Aogaichi K, Morganroth J, Brazzell RK (1984) Single-dose pharmacokinetics and dose proportionality of oral cibenzoline. J Clin Pharmacol 24: 283–288Google Scholar
  8. 8.
    Melander A (1978) Influence of food on the bioavailability of drugs. Clin Pharmacokinet 3: 337–351Google Scholar
  9. 9.
    Miller JS, Vaughn-Williams EM (1982) Effects on rabbit nodal, atrial, ventricular and Purkinje cell potentials of a new antiarrhythmic drug, cibenzoline, which protects against action potential shortening in hypoxia. Br J Pharmacol 75: 469–478Google Scholar
  10. 10.
    Polasa K, Krishnaswamy K (1983) Effect of food on bioavailability of rifampicin. J Clin Pharmacol 23: 433–437Google Scholar
  11. 11.
    Van den Brand M, Serruys P, de Roon Y, Aymard MF, Dufour A (1984) Haemodynamic effects of intravenous cibenzoline in patients with coronary heart disease. Eur J Clin Pharmacol 26: 297–302Google Scholar
  12. 12.
    Welling PG (1977) Influence of food and diet on gastrointestinal drug absorption: A review. J Pharmacokinet Biopharm 5: 291–334Google Scholar

Copyright information

© Springer-Verlag 1986

Authors and Affiliations

  • J. W. Massarella
    • 1
  • H. P. Blumenthal
    • 2
  • T. Silvestri
    • 1
  • A. Lin
    • 3
  1. 1.Department of Drug MetabolismHoffmann-La Roche Inc.NutleyUSA
  2. 2.Department of Clinical Research and DevelopmentHoffmann-La Roche Inc.NutleyUSA
  3. 3.Department of Research StatisticsHoffmann-La Roche Inc.NutleyUSA

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