Haematologica
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Haematologica, Vol 91, Issue 12, 1685-1688
Copyright © 2006 by Ferrata Storti Foundation

Comparative Study

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

M de Montalembert, D Bachir, A Hulin, L Gimeno, A Mogenet, JL Bresson, I Macquin-Mavier, F Roudot-Thoraval, A Astier, and F Galacteros

Service de Pediatrie Generale, Hopital Necker, Paris, France. mariane.demontal@nck.aphp.fr

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.


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O. S. Platt
Hydroxyurea for the Treatment of Sickle Cell Anemia
N. Engl. J. Med., March 27, 2008; 358(13): 1362 - 1369.
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