Single Dose Two-periods Crossover Bioequivalence Study of Darifenacin Tablets in Healthy Volunteers.
Status:
Unknown status
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Center for Clinical Pharmacology Research Bdbeq S.A.
Collaborators:
Laboratorio Elea Phoenix S.A. Laboratorio Elea S.A.C.I.F. y A.