Allergic Rhinoconjunctivitis Clinical Trial
Official title:
A Multicentre, International, Adaptive, Open-label, Repeated Administration Pharmacokinetic Study of Bilastine in Children From 2 to <12 Years of Age With Allergic Rhinoconjunctivitis or Chronic Urticaria
The conduct of this clinical trial is aimed at determining the most suitable dose regimen for children in different age groups, and secondarily to assess the safety and tolerability of bilastine in this paediatric population subset.
The objective of this study is to assess the pharmacokinetics of bilastine in children (aged
2 to <12 years) with allergic rhinoconjunctivitis (seasonal allergic rhinitis [SAR] and/or
perennial allergic rhinitis [PAR]) or chronic urticaria (CU) in order to ascertain that the
systemic exposure attained with a dose of 10 mg/QD or lower is comparable to that achieved
in adults and adolescents administered with a dose of 20 mg/QD.
Additional objectives are to describe the safety and tolerability of a repeated
administration of bilastine in children with AR or CU.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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