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Completed

NCT Number: NCT03670095

Study in Healthy Subjects to Compare Two Tablet 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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shuguang Hospital, Shanghai TCM University

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactose-free memantine

Drug

Lactose-free memantine tablet, 10 mg; orally as a single dose

Memantine

Drug

Lactose-containing memantine tablet, 10 mg, orally as a single dose

Other names: Ebixa®

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. tmax in fed state for test and reference treatment

    Time frame: From zero to 72 hours post dose

    Nominal time corresponding to the occurrence of Cmax

  2. tmax in fasted state for test and reference treatment

    Time frame: From zero to 72 hours post dose

    Nominal time corresponding to the occurrence of Cmax

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2018
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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