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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lactose-free memantine; Drug: Memantine

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shuguang Hospital, Shanghai TCM University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactose-free memantine tablet; (treatment A - test) - 10 mg; orally as a single dose in fed and fasted state	Drug: Lactose-free memantine; Lactose-free memantine tablet, 10 mg; orally as a single dose
Experimental: Lactose-containing memantine tablet (Ebixa®); (treatment B - reference) - 10 mg, orally as a single dose in fed and fasted state	Drug: Memantine; Lactose-containing memantine tablet, 10 mg, orally as a single dose; Other Names: Ebixa®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Nominal time corresponding to the occurrence of Cmax	From zero to 72 hours post dose

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): December 24, 2018
• Study Completion (Actual): December 24, 2018

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Memantine
• Other Study ID Numbers: 17773A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No