Single Dose Bioequivalence Study of Darifenacin Tablets 7.5 mg in Fed Healthy Volunteers.
Status:
Unknown status
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
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.
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.