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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lactose-free memantine; Drug: Memantine

• Registration Number: NCT03670095
• Lead Sponsor: H. Lundbeck A/S

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.

Study Timeline

• Study Start: 2018-08-28
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Primary Completion: 2018-12-24
• Study Completion: 2018-12-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactose-free memantine tablet	Lactose-free memantine	(treatment A - test) - 10 mg; orally as a single dose in fed and fasted state
Lactose-containing memantine tablet (Ebixa®)	Memantine	(treatment B - reference) - 10 mg, orally as a single dose in fed and fasted state

Primary Outcome Measures

Name	Time	Method
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
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
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shuguang Hospital, Shanghai TCM University; 🇨🇳 Shanghai, China