Pharmacokinetics of hydroxyurea 1,000 mg coated breakable tablets and 500 mg capsules in pediatric and adult patients with sickle cell disease

Haematologica. 2006 Dec;91(12):1685-8.

Abstract

Little is known about the pharmacokinetics of hydroxyurea in patients with sickle cell disease (SCD). Our aims were to evaluate bioequivalence between standard hydroxyurea capsules and a new formulation of 1,000 mg coated breakable tablets in adults and to compare pharmacokinetic parameters in adults and children with SCD. Fifteen adults received hydroxyurea capsules and tablets in a randomized cross-over study. Eleven children received hydroxyurea tablets. The results showed bioequivalence between capsules and tablets in adults. Pharmacokinetic parameters were not significantly different between adults and children. Considerable inter-individual variability was noted.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Anemia, Sickle Cell / blood*
  • Anemia, Sickle Cell / drug therapy
  • Capsules
  • Chemistry, Pharmaceutical
  • Child
  • Child, Preschool
  • Cross-Over Studies
  • Humans
  • Hydroxyurea / blood*
  • Hydroxyurea / pharmacokinetics*
  • Hydroxyurea / therapeutic use
  • Middle Aged
  • Tablets, Enteric-Coated

Substances

  • Capsules
  • Tablets, Enteric-Coated
  • Hydroxyurea