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

Study Overview
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Brief Summary
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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
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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
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lactose-free memantine
* Drug: Memantine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactose-free memantine tablet<br>(treatment A - test) - 10 mg; orally as a single dose in fed and fasted state | Drug: Lactose-free memantine<br>* Lactose-free memantine tablet, 10 mg; orally as a single dose<br>|
| Experimental: Lactose-containing memantine tablet (Ebixa®)<br>(treatment B - reference) - 10 mg, orally as a single dose in fed and fasted state | Drug: Memantine<br>* Lactose-containing memantine tablet, 10 mg, orally as a single dose<br>* Other names: Ebixa®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-72h in fed state for test and reference treatment | Area under the memantine plasma concentration-time curve | From zero to 72 hours post dose | 
| AUC0-72h in fasted state for test and reference treatment | Area under the memantine plasma concentration-time curve | From zero to 72 hours post dose | 
| Cmax of memantine in fed state for test and reference treatment | Maximum observed plasma concentration of memantine | From zero to 72 hours post dose | 
| Cmax of memantine in fasted state for test and reference treatment | Maximum observed plasma concentration of memantine | From zero to 72 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax in fed state for test and reference treatment | Nominal time corresponding to the occurrence of Cmax | From zero to 72 hours post dose | 
| tmax in fasted state for test and reference treatment | Nominal time corresponding to the occurrence of Cmax | From zero to 72 hours post dose |