NCT01081574

Pharmacokinetic Study of Bilastine in Children From 2 to < 12 Years of Age With Either Allergic Rhinoconjunctivitis (AR) or Chronic Urticaria (CU)

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Faes Farma, S.A. · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Allergic Rhinoconjunctivitis
• Chronic Urticaria

Interventions

Type	Name	Description
DRUG	Bilastine	10 mg/qd/ 7 days.Oral dispersible tablets

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-03-05
• Last updated: 2012-09-26

Locations

7 sites across 3 countries: Australia, Germany, Sweden