Pharmacokinetics of hydroxyurea 1,000 mg coated breakable tablets and 500 mg capsules in pediatric and adult patients with sickle cell disease.
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.
de Montalembert
Mariane
M
Service de Pédiatrie Générale, Hôpital Necker, Paris, France. mariane.demontal@nck.aphp.fr
Bachir
Dora
D
Hulin
Anne
A
Gimeno
Linda
L
Mogenet
Agnès
A
Bresson
Jean Louis
JL
Macquin-Mavier
Isabelle
I
Roudot-Thoraval
Françoise
F
Astier
Alain
A
Galactéros
Frédéric
F
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
D002214:Capsules; D013608:Tablets, Enteric-Coated; D006918:Hydroxyurea