Abstract
Methods A popPK model was developed, using data from 6-11 y/o study (STD I) including 11 patients with full PK profile in allergic rhinitis. A second study (STD2) including 2-5 y/o was optimal designed based on the parameters estimated from STD I, assuming: inclusion of 25 kg) and 3 samples per child were needed in a 2h time window. A twocompartmental model with first-order absorption and elimination where clearance depends on weight fitted the data for 2-11 y/o children. Mean (SD) estimates of parameters obtained by noncompartmental analysis of the steady-state simulated plasma concentrations for both subsets of children were similar: Cmax, 2.54(1.26) vs 1.96(0.52) ng/mL; AUC, 10.74(3.09) vs 10.38(4.31) ng/mL/h; t1/2, 12.28(3.09) vs 15.94(4.09), for children 6-11 y/o and children 2-5 y/o, respectively.
Highlights
Rupatadine is a second generation antihistamine H1 and antagonist of PAF for the treatment of allergic rhinitis and urticaria for which a new pediatric oral solution is available for children between 6-11 y/o
The dose administered in STD II was 2.5 mg/kg or 5 mg/kg and 3 samples per child were needed in a 2h time window
Mean (SD) estimates of parameters obtained by noncompartmental analysis of the steady-state simulated plasma concentrations for both subsets of children were similar: Cmax, 2.54(1.26) vs 1.96(0.52) ng/mL; AUC, 10.74(3.09) vs 10.38(4.31) ng/mL/h; t1/2, 12.28(3.09) vs 15.94(4.09), for children 6-11 y/o and children 2-5 y/o, respectively
Summary
1) To optimize the dose regime in children between2 to 5 y/o old to reach similar plasma concentrations to children of 6-11 y/o with allergic rhinitis.2) To build a new population pharmacokinetic (popPK) model in children including all ages (2-11 y/o) to evaluate if the proposed regimen, as a function of weight, is adequate to reach rupatadine exposure similar to adults and ≥ 12 y/o. 1) To optimize the dose regime in children between. 2 to 5 y/o old to reach similar plasma concentrations to children of 6-11 y/o with allergic rhinitis. 2) To build a new population pharmacokinetic (popPK) model in children including all ages (2-11 y/o) to evaluate if the proposed regimen, as a function of weight, is adequate to reach rupatadine exposure similar to adults and ≥ 12 y/o
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