Study in Healthy Subjects to Compare Two Tablet Formulations of Memantine (Ebixa®) in Fasted and Fed Conditions

H. Lundbeck A/S64 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Lactose-free memantineDRUG

Lactose-free memantine tablet, 10 mg; orally as a single dose

MemantineDRUG

Lactose-containing memantine tablet, 10 mg, orally as a single dose

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy men and women ≥18 years of age with a body mass index (BMI) ≥18.5 and ≤28 kg/m2. * Women must be non-pregnant and non-lactating. Exclusion Criteria: \- The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP. Other in- and exclusion criteria may apply

Locations (1)

Shuguang Hospital, Shanghai TCM University

Shanghai, China