Darifenacin is a muscarinic receptor antagonist drug used to treat overactive bladder. There is a new formulation of darifenacin extended release developed by an argentinian pharmaceutical company and, according to regional regulations, a bioequivalence study should be performed to put it in the market.~The purpose of this study is to evaluate the relative bioavailability and pharmacokinetic profiling of a brand generic formulation of darifenacin [Darisec(R) 15 mg] vs. the innovator [Enablex(R) 15 mg] in 24 healthy uruguayan volunteers after a high fat breakfast of 1000 calories (50% fat, 35% carbohydrates (sugar, flour, etc.) and 15& proteins) to establish their average bioequivalence.~The bioequivalence will be evaluated using outcome measures that will be described later.~The pharmacokinetic characteristics of the drugs will be described calculating:~the time to Cmax (Tmax)~the elimination constant (Ke),~the elimination half-life (t1/2e)and,~the systemic clearance (Cls.~Safety will be evaluated recording:~vital signs (blood pressure, heart rate, body temperature)~adverse events,~laboratory analysis (hemogram, hepatic enzymes, creatinine, sugar in blood,etc.).~EKG and chest XRays.~Bioequivalence will be claimed if the drugs comply with local and FDA regulatory requirement, eg.:~mean AUCt/AUCr and 90% confidence interval within 0.80-1.25~mean Cmaxt/Cmaxr and 90% confidence interval within 0.80-1.25.~Safety will be evaluated comparing incidences of adverse events/adverse effects for both products.
The present study was designed to assess the bioequivalence and pharmacokinetic profiling of a brand generic formulation of darifenacin [Darisec(R)]vs. the innovator [Enablex(R)]in healthy volunteers after a high fat breakfast.~The bioequivalence will be evaluated using:~the Area Under the Curve (AUC) and,~the peak plasma concentration (Cmax).~Safety will be evaluated recording:~vital signs~adverse events,~laboratory analysis.~EKG and chest XRays.~Bioequivalence will be claimed if the drugs comply with local regulatory requirement, eg.:~mean AUCt/AUCr and 90% confidence interval within 0.80-1.25~mean Cmaxt/Cmaxr and 90% confidence interval within 0.80-1.25.