title: Pharmacokinetics of hydroxyurea 1,000 mg coated breakable tablets and 500 mg capsules in pediatric and adult patients with sickle cell disease.
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.
authors.affiliation: Service de Pédiatrie Générale, Hôpital Necker, Paris, France. mariane.demontal@nck.aphp.fr
authors.forename: Mariane
authors.initials: M
authors.lastname: de Montalembert
authors.forename: Dora
authors.initials: D
authors.lastname: Bachir
authors.forename: Anne
authors.initials: A
authors.lastname: Hulin
authors.forename: Linda
authors.initials: L
authors.lastname: Gimeno
authors.forename: Agnès
authors.initials: A
authors.lastname: Mogenet
authors.forename: Jean Louis
authors.initials: JL
authors.lastname: Bresson
authors.forename: Isabelle
authors.initials: I
authors.lastname: Macquin-Mavier
authors.forename: Françoise
authors.initials: F
authors.lastname: Roudot-Thoraval
authors.forename: Alain
authors.initials: A
authors.lastname: Astier
authors.forename: Frédéric
authors.initials: F
authors.lastname: Galactéros
mesh_terms: D000293:Adolescent; D000328:Adult; D000755:Anemia, Sickle Cell / Q000097:blood* / Q000188:drug therapy; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D006801:Humans; D006918:Hydroxyurea / Q000097:blood* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D008875:Middle Aged; D013608:Tablets, Enteric-Coated
chemical_list: D002214:Capsules; D013608:Tablets, Enteric-Coated; D006918:Hydroxyurea