Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactose-free memantine tablet | Experimental | (treatment A - test) - 10 mg; orally as a single dose in fed and fasted state |
|
| Lactose-containing memantine tablet (Ebixa®) | Experimental | (treatment B - reference) - 10 mg, orally as a single dose in fed and fasted state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactose-free memantine | Drug | Lactose-free memantine tablet, 10 mg; orally as a single dose |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shuguang Hospital, Shanghai TCM University | Shanghai | China |
Not provided
| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Memantine | Drug | Lactose-containing memantine tablet, 10 mg, orally as a single dose |
|
|
Nominal time corresponding to the occurrence of Cmax
| From zero to 72 hours post dose |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |