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Bioequivalence Evaluation of three Pediatric Oral Formulations of Bilastine in Healthy Subjects

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eMediNexus    13 January 2023

Bilastine, a non-sedating H1 antihistamine, is approved for treating allergic rhinoconjunctivitis and urticaria. The present trial assessed the bioequivalence of three novel pediatric oral formulations of bilastine.

 

This open-label, randomized, four-treatment-period, four-sequence, crossover, single-center study enrolled 23 healthy volunteers who received four single doses of bilastine under fasting conditions: a 10-mg orodispersible tablet (DT1), a 10-mg oral solution (SOL), a 10-mg orodispersible tablet without water (DT2dry), and a 10-mg orodispersible tablet with water (DT2water, reference formulation). The study collected the blood samples for 72 h with a washout period of at least seven days. It calculated Bilastine maximum plasma concentration (Cmax) and area under the plasma concentration-time curve between 0 to t time (AUC0-t) to assess bioequivalence. It evaluated tolerability throughout the intervention.

 

The study observed-

 

  • Bioequivalence of the three oral pediatric formulations tested to the reference formulation as determined by the ratio test/reference of the geometric mean and their 90% confidence intervals (between 0.80 and 1.25) for the Cmax, AUC0-t, and AUC0-∞.
  • Well-tolerance of Bilastine when administered indistinctly as an orodispersible tablet or as an oral solution.

 

This study found the three oral pediatric formulations tested are bioequivalent to the reference formulation, with good tolerability.

 

Eur J Drug Metab Pharmacokinet. 2020 Apr;45(2):265-272. doi: 10.1007/s13318-019-00596-2. PMID: 31820304.

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