Pharmacokinetics of hydroxyurea 1,000 mg coated breakable tablets and 500 mg capsules in pediatric and adult patients with sickle cell disease
de Montalembert, M.; Bachir, D.; Hulin, A.; Gimeno, L.; Mogenet, Aès.; Bresson, J.Louis.; Macquin-Mavier, I.; Roudot-Thoraval, Fçoise.; Astier, A.; Galactéros, Fédéric.
Haematologica 91(12): 1685-1688
2006
ISSN/ISBN: 0390-6078 PMID: 17145606 Document Number: 600260
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.