Study in Healthy Subjects to Compare Two Tablet Formulations of Memantine (Ebixa®) in Fasted and Fed Conditions
brief summary
The purpose of this study is to investigate the release of memantine into the bloodstream of two different formulations: one formulation containing lactose and one without lactose.
detailed description
The study consists of two cohorts: A1 and A2.
Subjects in Cohort A1 will be administered the investigational medicinal product (IMP) in a fasted state and subjects in Cohort A2 will be administered the IMP in a fed state.
Each subject will change cohort during study participation, so that dosing will be done over two periods: either first fed and then fasted, or first fasted and then fed. The two periods will be separated by a period of 28 days (+7 days) where no investigational medicinal product is given.
All subjects will be confined to the clinic from one day prior to dosing until Day 4 (72 hours post-dose) in each dosing period.
official title
Interventional, Randomized, Single-dose, Open-label, Crossover, Bioequivalence Study in Healthy Subjects to Compare Two Pharmaceutical Formulations of Memantine (Ebixa®) in Fasted and Fed Conditions