Hydroxyurea (HU) is recommended for all children starting as young as 9 months of age with sickle cell anemia (SCA; HbSS and HbSβ0 thalassemia); however, a paucity of pediatric data exists regarding the pharmacokinetics (PK) or the exposure-response relationship of HU. This trial aimed to characterize the PK of HU in children and to evaluate and compare the bioavailability of a liquid versus capsule formulation. This multi-center, prospective, open-label trial enrolled 39 children with SCA who provided 682 plasma samples for PK analysis following administration of HU. Noncompartmental and population PK models are described. We report that liquid and capsule formulations of HU are bioequivalent, weight-based dosing schemes provide consistent drug exposure, and age-based dosing schemes are unnecessary.

 

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