Bioequivalence Evaluation of Three Pediatric Oral Formulations of Bilastine in Healthy Subjects: Results from a Randomized, Open Label, Crossover Study.
Administration, Oral
Adolescent
Adult
Area Under Curve
Benzimidazoles
/ administration & dosage
Cross-Over Studies
Fasting
Female
Histamine H1 Antagonists, Non-Sedating
/ administration & dosage
Humans
Male
Pharmaceutical Solutions
Piperidines
/ administration & dosage
Tablets
Therapeutic Equivalency
Young Adult
Journal
European journal of drug metabolism and pharmacokinetics
ISSN: 2107-0180
Titre abrégé: Eur J Drug Metab Pharmacokinet
Pays: France
ID NLM: 7608491
Informations de publication
Date de publication:
Apr 2020
Apr 2020
Historique:
pubmed:
11
12
2019
medline:
1
12
2020
entrez:
11
12
2019
Statut:
ppublish
Résumé
Bilastine is a non-sedating H1 antihistamine indicated for the treatment of allergic rhinoconjunctivitis and urticaria. The aim of this trial was to assess the bioequivalence of three novel pediatric oral formulations of bilastine. An open label, randomized, four-treatment-period, four-sequence, crossover, single-center study was conducted in 23 healthy volunteers. Each subject 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). Blood samples were collected during 72 h with a washout period of at least 7 days. Bilastine maximum plasma concentration (C The three oral pediatric formulations tested were bioequivalent 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 C The three oral pediatric formulations tested were found to be bioequivalent to the reference formulation. All formulations were well tolerated. Spanish Clinical Studies Registry (REEC) number 2014-000786-41.
Sections du résumé
BACKGROUND AND OBJECTIVE
OBJECTIVE
Bilastine is a non-sedating H1 antihistamine indicated for the treatment of allergic rhinoconjunctivitis and urticaria. The aim of this trial was to assess the bioequivalence of three novel pediatric oral formulations of bilastine.
METHODS
METHODS
An open label, randomized, four-treatment-period, four-sequence, crossover, single-center study was conducted in 23 healthy volunteers. Each subject 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). Blood samples were collected during 72 h with a washout period of at least 7 days. Bilastine maximum plasma concentration (C
RESULTS
RESULTS
The three oral pediatric formulations tested were bioequivalent 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 C
CONCLUSION
CONCLUSIONS
The three oral pediatric formulations tested were found to be bioequivalent to the reference formulation. All formulations were well tolerated.
TRIAL REGISTRATION
BACKGROUND
Spanish Clinical Studies Registry (REEC) number 2014-000786-41.
Identifiants
pubmed: 31820304
doi: 10.1007/s13318-019-00596-2
pii: 10.1007/s13318-019-00596-2
doi:
Substances chimiques
Benzimidazoles
0
Histamine H1 Antagonists, Non-Sedating
0
Pharmaceutical Solutions
0
Piperidines
0
Tablets
0
bilastine
PA1123N395
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
265-272Subventions
Organisme : FAES FARMA S.A. (Spain)
ID : unknown
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