PMID- 37655364
OWN - NLM
STAT- MEDLINE
DCOM- 20231204
LR  - 20240416
IS  - 2160-7648 (Electronic)
IS  - 2160-763X (Linking)
VI  - 12
IP  - 12
DP  - 2023 Dec
TI  - Bioequivalence of 2 Pediatric Formulations of Fexofenadine Hydrochloride Oral 
      Suspension.
PG  - 1194-1203
LID - 10.1002/cpdd.1311 [doi]
AB  - Fexofenadine hydrochloride (HCl) is a second-generation, nonsedating, histamine 
      H1-receptor antagonist used to manage seasonal allergic rhinitis and chronic 
      idiopathic urticaria. A new oral pediatric suspension of fexofenadine HCl has 
      been developed, with the preservative potassium sorbate replacing parabens. The 
      objective of this phase 1 single-center, open-label, randomized, 2-treatment, 
      full-replicated, 4-period, 2-sequence crossover study in healthy adult volunteers 
      was to assess the bioequivalence of 30 mg of the new oral suspension of 
      fexofenadine HCl (test) versus 30 mg of the marketed pediatric oral suspension of 
      fexofenadine HCl (reference). The replicate design was based on the high 
      intra-individual variability of fexofenadine (>30% on C(max) ). The study 
      comprised 68 randomized and treated volunteers. Plasma concentrations of 
      fexofenadine were similar following the administration of a single dose of each 
      formulation. C(max) , AUC(last) , AUC, median t(max) , and mean t(1/2z) were 
      similar between administrations of the same fexofenadine formulation and between 
      formulations. A high intra-individual variability was confirmed with both 
      formulations. Bioequivalence of the test and reference fexofenadine HCl 
      formulations was demonstrated as the 90% confidence intervals of the geometric 
      least squares mean ratio for C(max) , AUC(last) , and AUC of fexofenadine were 
      all within the bioequivalence range of 0.80-1.25. There were no serious adverse 
      events (AEs) or study discontinuations due to treatment-emergent AEs with either 
      fexofenadine HCl formulation. The new paraben-free fexofenadine HCl 30-mg oral 
      suspension and marketed fexofenadine HCl 30-mg pediatric oral suspension are 
      bioequivalent under fasting conditions, with no safety concerns and a safety 
      profile consistent with the known profile of fexofenadine.
CI  - (c) 2023 Sanofi and The Authors. Clinical Pharmacology in Drug Development 
      published by Wiley Periodicals LLC on behalf of American College of Clinical 
      Pharmacology.
FAU - Rauch, Clemence
AU  - Rauch C
AD  - Clinical Development & Biometry, Sanofi CHC, Gentilly, France.
FAU - Lucio, Luiz
AU  - Lucio L
AD  - Allergy, Sanofi CHC, Sao Paulo, Brazil.
FAU - De Fer, Beatrice Bois
AU  - De Fer BB
AD  - Clinical Development & Biometry, Sanofi CHC, Gentilly, France.
FAU - Lheritier-Barrand, Michele
AU  - Lheritier-Barrand M
AD  - Science Innovation, Sanofi CHC, Gentilly, France.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230901
PL  - United States
TA  - Clin Pharmacol Drug Dev
JT  - Clinical pharmacology in drug development
JID - 101572899
RN  - E6582LOH6V (fexofenadine)
RN  - 7BA5G9Y06Q (Terfenadine)
RN  - 0 (Histamine H1 Antagonists)
RN  - 0 (Histamine H1 Antagonists, Non-Sedating)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Child
MH  - Therapeutic Equivalency
MH  - Cross-Over Studies
MH  - *Terfenadine/adverse effects
MH  - Histamine H1 Antagonists
MH  - *Histamine H1 Antagonists, Non-Sedating/adverse effects
OTO - NOTNLM
OT  - bioequivalence
OT  - chronic idiopathic urticaria
OT  - fexofenadine hydrochloride
OT  - formulations
OT  - pediatric
OT  - pharmacokinetics
OT  - seasonal allergic rhinitis
EDAT- 2023/09/01 06:42
MHDA- 2023/12/04 12:42
CRDT- 2023/09/01 04:13
PHST- 2023/04/13 00:00 [received]
PHST- 2023/07/04 00:00 [accepted]
PHST- 2023/12/04 12:42 [medline]
PHST- 2023/09/01 06:42 [pubmed]
PHST- 2023/09/01 04:13 [entrez]
AID - 10.1002/cpdd.1311 [doi]
PST - ppublish
SO  - Clin Pharmacol Drug Dev. 2023 Dec;12(12):1194-1203. doi: 10.1002/cpdd.1311. Epub 
      2023 Sep 1.