Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2008
Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial formulation in both under fasted and fed condition, and bioequivalence between formulation E(1) used in Japanese pivotal study and commercial formulation in 8 mg. Secondary objective is to assess food effect on 8 mg tablet of commercial formulation. These objectives are set to get data for Japanese regulatory submission.
Epistemonikos ID: 9ebc1a05371ba674089520b2b97fe770424ce136
First added on: May 05, 2024