Simultaneous first-order and capacity-limited elimination kinetics after oral administration of verapamil

J Clin Pharmacol. 1996 Jan;36(1):25-34. doi: 10.1002/j.1552-4604.1996.tb04148.x.

Abstract

In this study of the relationship between dose and plasma concentration of verapamil, controlled-release verapamil in doses of 120 mg, 180 mg, 360 mg, and 540 mg were examined. The 48 study subjects received verapamil daily during each of the 4 sequential 5-day dosing segments. Blood samples were collected frequently to obtain first-dose and steady-state (fifth dose) concentration profiles of verapamil. Plasma concentrations of R- and S-verapamil and R- and S-norverapamil were measured by stereospecific assay. Statistical comparisons of pharmacokinetic parameters and mean differences between doses were performed with analysis of variance models. At steady state, area under the concentration-time curve (AUC) values for R- and S-verapamil at both the 120-mg and 180-mg doses were about 1.5 times higher than the corresponding first-dose values. After both first and fifth doses, pharmacokinetic parameters for all four analytes were dose proportional between the 120-mg and 180-mg doses. A dose-proportional relationship also was found between the 360-mg and 540-mg dose levels. However, nonlinearity was found between the 180-mg dose and higher doses, suggesting saturable metabolic pathways. The dose-proportional relationship between the 360-mg and 540-mg doses suggests that other first-order metabolic pathways become dominant. Although results from this study are partially consistent with previously reported nonlinear verapamil kinetics, this is the first clinical study to demonstrate a dose-proportional relationship for verapamil at both low and high input rates (mg/hr). In addition, first-order disposition pathways of verapamil are probably nonexistent at medium input rates and become dominant at higher input rates.

Publication types

  • Comparative Study

MeSH terms

  • Administration, Oral
  • Adult
  • Calcium Channel Blockers / blood
  • Calcium Channel Blockers / pharmacokinetics*
  • Delayed-Action Preparations
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Humans
  • Male
  • Middle Aged
  • Verapamil / blood
  • Verapamil / pharmacokinetics*

Substances

  • Calcium Channel Blockers
  • Delayed-Action Preparations
  • Verapamil