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. A bioequivalence study will be performed to validate pharmaceutical development before introducing the product in the market.~The purpose in this study is to evaluate the relative bioavailability, pharmacokinetic profiling and safety of a brand generic formulation of darifenacin [Darisec(R) 7.5 mg] vs. the innovator [Enablex(R) 7.5 mg]in 24 healthy uruguayan volunteers after a high fat breakfast of 1000 calories (50% fat, 35% carbohydrates, and 15% proteins)to establish their average bioequivalence.~The bioequivalence will be evaluated using:~The Area Under the Curve (AUC),~The peak plasma concentration (Cmax).~The pharmacokinetic characteristics of the drug formulations will be described calculating:~The time to peak concentration (Tmax)~The elimination constant (Ke)~The elimination half-life (t1/2e)~The systemic clearance (Cls)~Safety will be evaluated recording:~Reported adverse events~Vital signs (blood pressure, heart rate, body temperature)~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 requirements:~Mean AUCt/AUCr and 90% confidence interval within 0.80-1.25~Mean Cmaxt/Cmaxr and 90% confidence interval within 0.80-1.25~Pharmacokinetic profiling will be evaluated by describing the pharmacokinetic characteristics of both drug in adequate two-way tables.~Safety will be evaluated comparing incidence of adverse events/adverse effects for both products.
The proposed study was designed as a randomized two-sequence, two period crossover trial to assess the bioequivalence, pharmacokinetic profiling and safety of a brand generic formulation of darifenacin [Darisec(R) 7.5 mg] vs. the innovator [Enablex(R)7.5 mg]in healthy volunteers in postprandial state.