The pharmacokinetics and safety of desvenlafaxine in subjects with chronic renal impairment

Int J Clin Pharmacol Ther. 2011 Jan;49(1):3-13. doi: 10.5414/cpp49003.

Abstract

Background: Desvenlafaxine (administered as desvenlafaxine succinate), the major active metabolite of venlafaxine, is a new serotonin-norepinephrine reuptake inhibitor (SNRI) approved for the treatment of major depressive disorder (MDD).

Objective: To assess the pharmacokinetics, safety, and tolerability of desvenlafaxine in healthy volunteers vs. those with renal impairment.

Materials and methods: A single, oral, 100 mg dose of desvenlafaxine was administered to healthy subjects (n = 8) and subjects with mild (n = 9), moderate (n = 9), or severe (n = 7) renal impairment (24-h creatinine clearance, ml/min: 50 - 80, 30 - 50, or < 30 ml/min, respectively) or end-stage renal disease (ESRD; on dialysis.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Area Under Curve
  • Cyclohexanols / adverse effects
  • Cyclohexanols / pharmacokinetics*
  • Desvenlafaxine Succinate
  • Female
  • Humans
  • Kidney Failure, Chronic / metabolism*
  • Male
  • Middle Aged
  • Neurotransmitter Uptake Inhibitors / pharmacokinetics*
  • Stereoisomerism

Substances

  • Cyclohexanols
  • Neurotransmitter Uptake Inhibitors
  • Desvenlafaxine Succinate