Healthy
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.
Interventions
DRUGLactose-free memantine
Lactose-free memantine tablet, 10 mg; orally as a single dose
DRUGMemantine
Lactose-containing memantine tablet, 10 mg, orally as a single dose
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-72h in fed state for test and reference treatment | From zero to 72 hours post dose | Area under the memantine plasma concentration-time curve |
| AUC0-72h in fasted state for test and reference treatment | From zero to 72 hours post dose | Area under the memantine plasma concentration-time curve |
| Cmax of memantine in fed state for test and reference treatment | From zero to 72 hours post dose | Maximum observed plasma concentration of memantine |
| Cmax of memantine in fasted state for test and reference treatment | From zero to 72 hours post dose | Maximum observed plasma concentration of memantine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tmax in fed state for test and reference treatment | From zero to 72 hours post dose | Nominal time corresponding to the occurrence of Cmax |
| tmax in fasted state for test and reference treatment | From zero to 72 hours post dose | Nominal time corresponding to the occurrence of Cmax |
Countries
China
Outcome results
None listed