Single Dose Two-periods Crossover Bioequivalence Study of Darifenacin Tablets in Healthy Volunteers.

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.