Premium
Pharmacokinetics and Bioequivalence Estimation of Two Formulations of Alfuzosin Extended‐Release Tablets
Author(s) -
Al Bawab Abdel Qader,
Alkhalidi Bashar A.,
Albarahmieh Esra'a,
Qassim Sami M.A.,
AlSaifi Mohammad A.D.,
AlSaifi Bashar,
Ling Jonathan,
AlQerem Walid
Publication year - 2020
Publication title -
clinical pharmacology in drug development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.711
H-Index - 22
eISSN - 2160-7648
pISSN - 2160-763X
DOI - 10.1002/cpdd.860
Subject(s) - bioequivalence , medicine , pharmacokinetics , bioavailability , alfuzosin , confidence interval , crossover study , pharmacology , area under the curve , food and drug administration , urology , oral administration , lower urinary tract symptoms , prostate , alternative medicine , pathology , cancer , placebo
Alfuzosin is a medication approved by the US Food and Drug Administration to treat benign prostatic hyperplasia symptoms. Bioequivalence studies are demanded by regulatory authorities to evaluate the expected in vivo biological similarity of 2 formulations of a medication. The aim of this study is to assess the bioavailability of the generic (test) and branded (reference) formulations of 10‐mg alfuzosin extended‐release tablets after oral administration to healthy adults under fed conditions. The study used a comparative randomized, single‐dose, 2‐way crossover open‐label study design. Thirty‐three participants were recruited and completed the clinical assessment. The pharmacokinetic parameters maximum plasma concentration (C max ), area under the plasma concentration–time curve (AUC 0‐t ), AUC extrapolated to infinity (AUC 0‐∞ ), time to maximum concentration, and elimination half‐life were estimated to prove bioequivalence. The confidence intervals for the log‐transformed test/reference ratios for alfuzosin 110.7% (98.0–124.9) and 112.0% (101.9–123.1) for C max and AUC 0‐t respectively, which are within the allowed limits specified by the regulatory authorities (80–125% for C max and AUC 0‐t ). The test formulation can therefore be prescribed as an alternative to the reference for symptomatic treatment of benign prostatic hyperplasia.