Study in Healthy Subjects to Compare Two Tablet Formulations of Memantine (Ebixa®) in Fasted and Fed Conditions
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
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2018
CompletedFirst Submitted
Initial submission to the registry
September 12, 2018
CompletedFirst Posted
Study publicly available on registry
September 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 24, 2018
CompletedFebruary 29, 2024
February 1, 2024
4 months
September 12, 2018
February 28, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
tmax in fed state for test and reference treatment
From zero to 72 hours post dose
tmax in fasted state for test and reference treatment
From zero to 72 hours post dose
Study Arms (2)
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
Interventions
Lactose-free memantine tablet, 10 mg; orally as a single dose
Lactose-containing memantine tablet, 10 mg, orally as a single dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
Shuguang Hospital, Shanghai TCM University
Shanghai, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2018
First Posted
September 13, 2018
Study Start
August 28, 2018
Primary Completion
December 24, 2018
Study Completion
December 24, 2018
Last Updated
February 29, 2024
Record last verified: 2024-02