ABSTRACT
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.
Subject(s)
Drug Compounding/statistics & numerical data , Prostatic Hyperplasia/drug therapy , Quinazolines/pharmacokinetics , Urological Agents/pharmacokinetics , Administration, Oral , Adult , Area Under Curve , Biological Availability , Cross-Over Studies , Cytochrome P-450 CYP3A/metabolism , Drug Compounding/methods , Drugs, Generic/pharmacokinetics , Half-Life , Healthy Volunteers , Humans , Male , Prostatic Hyperplasia/blood , Quinazolines/administration & dosage , Quinazolines/adverse effects , Therapeutic Equivalency , Urological Agents/administration & dosage , Urological Agents/adverse effectsABSTRACT
Dalfampridine is a medication that is approved by the US Food and Drug Administration to improve walking impairments in patients with multiple sclerosis (MS). The branded dalfampridine is enormously expensive; hence, the availability of generic dalfampridine will provide better access to the medication, especially for uninsured patients with MS. Bioequivalence studies are demanded by the regulatory authorities to allow the marketing of new generics of dalfampridine. The aim of this study was to assess the bioavailability of the generic (test) and branded (reference) formulations of 10 mg dalfampridine of extended-release tablets after oral administration to healthy adults under fed conditions. The current report methodology was based on a comparative, randomized, single-dose, 2-way crossover open-label study design. Twenty-seven subjects were given a single dose of the test dalfampridine tablet and completed the clinical study. The pharmacokinetic parameters Cmax and AUC0ât, Kel , AUC0â∞ , tmax , and t1/2el were estimated to prove bioequivalence. The confidence intervals for the log-transformed test/reference ratios for dalfampridine 100.96% (97.09%-104.97%) and 99.77% (95.81%-103.87%) for Cmax and AUC0â∞ , respectively, were within the allowed limit specified by the regulatory authorities (80%-125%). Hence, clinically, the test tablet can be prescribed as an alternative to the reference for the indication of improving walking impairments in patients with MS.
