Pharmacokinetics and Bioequivalence Estimation of Two Formulations of Alfuzosin Extended-Release Tablets.

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 (Cmax ), area under the plasma concentration-time curve (AUC0-t ), AUC extrapolated to infinity (AUC0-∞ ), 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 Cmax and AUC0-t respectively, which are within the allowed limits specified by the regulatory authorities (80-125% for Cmax and AUC0-t ). The test formulation can therefore be prescribed as an alternative to the reference for symptomatic treatment of benign prostatic hyperplasia.

Clinical pharmacology in drug development. 2020 Aug 07 [Epub ahead of print]

Abdel Qader Al Bawab, Bashar A Alkhalidi, Esra'a Albarahmieh, Sami M A Qassim, Mohammad A D Al-Saifi, Bashar Al-Saifi, Jonathan Ling, Walid Al-Qerem

Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman, Jordan., School of Pharmacy, The University of Jordan, Amman, Jordan., School of Applied Medical Sciences, German Jordanian University, Amman, Jordan., Tabuk Pharmaceuticals, Tabuk, Kingdom of Saudi Arabia., University of Sunderland, Sunderland, UK.