HealthyPhase 1NCT03670095
Study in Healthy Subjects to Compare Two Tablet Formulations of Memantine (Ebixa®) in Fasted and Fed Conditions
A Phase 1 study testing Lactose-free memantine and Memantine in people with Healthy, run by H. Lundbeck A/S at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactose-free memantine and Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2018to 24 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Lactose-free memantine, Memantine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactose-free memantineDrug
Lactose-free memantine tablet, 10 mg; orally as a single dose
MemantineDrug
Also called Ebixa®
Lactose-containing memantine tablet, 10 mg, orally as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Lactose-free memantine tablet | Experimental | (treatment A - test) - 10 mg; orally as a single dose in fed and fasted state Receives: Drug: Lactose-free memantine |
| Lactose-containing memantine tablet (Ebixa®) | Experimental | (treatment B - reference) - 10 mg, orally as a single dose in fed and fasted state Receives: Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-72h in fed state for test and reference treatment
Area under the memantine plasma concentration-time curve
Measured: 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
Measured: From zero to 72 hours post dose
Cmax of memantine in fed state for test and reference treatment
Maximum observed plasma concentration of memantine
Measured: From zero to 72 hours post dose
Cmax of memantine in fasted state for test and reference treatment
Maximum observed plasma concentration of memantine
Measured: From zero to 72 hours post dose
Secondary outcomes (2)
tmax in fed state for test and reference treatment
Nominal time corresponding to the occurrence of Cmax
Measured: From zero to 72 hours post dose
tmax in fasted state for test and reference treatment
Nominal time corresponding to the occurrence of Cmax
Measured: From zero to 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start28 Aug 2018
- Primary completion24 Dec 2018
- Study completion24 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670095
- Sponsor's protocol ID
- 17773A
- Status last verified
- Feb 2024
- First submitted
- 12 Sep 2018
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03670095
- Acronym / sponsor ID
- 17773A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 24 Dec 2018 (actual)
- Study completion
- 24 Dec 2018 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactose-free memantine tablet | Experimental | Drug: Lactose-free memantine(treatment A - test) - 10 mg; orally as a single dose in fed and fasted state |
| Lactose-containing memantine tablet (Ebixa®) | Experimental | Drug: Memantine(treatment B - reference) - 10 mg, orally as a single dose in fed and fasted state |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactose-free memantineLactose-free memantine tablet, 10 mg; orally as a single dose | Drug | Lactose-free memantine tablet |
| MemantineAlso: Ebixa®Lactose-containing memantine tablet, 10 mg, orally as a single dose | Drug | Lactose-containing memantine tablet (Ebixa®) |
Primary outcome
AUC0-72h in fed state for test and reference treatment
Time frame: 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
Time frame: 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
Time frame: From zero to 72 hours post dose
Maximum observed plasma concentration of memantine
Cmax of memantine in fasted state for test and reference treatment
Time frame: From zero to 72 hours post dose
Maximum observed plasma concentration of memantine
2 secondary outcomes
tmax in fed state for test and reference treatment
Time frame: From zero to 72 hours post dose
tmax in fasted state for test and reference treatment
Time frame: From zero to 72 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactose-free memantine and Memantine in people with Healthy, run by H. Lundbeck A/S at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-72h in fed state for test and reference treatment (time frame: From zero to 72 hours post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.