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

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT03670095
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
3.9
Actual Duration (Months)
16.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 28, 2018
Actual Primary Completion Date :
Dec 24, 2018
Actual Study Completion Date :
Dec 24, 2018

Arms and Interventions

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®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. Cmax of memantine in fed state for test and reference treatment [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 [From zero to 72 hours post dose]

      Maximum observed plasma concentration of memantine

    Secondary Outcome Measures

    1. tmax in fed state for test and reference treatment [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 [From zero to 72 hours post dose]

      Nominal time corresponding to the occurrence of Cmax

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shuguang Hospital, Shanghai TCM University Shanghai China

    Sponsors and Collaborators

    • H. Lundbeck A/S

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    H. Lundbeck A/S
    ClinicalTrials.gov Identifier:
    NCT03670095
    Other Study ID Numbers:
    • 17773A
    First Posted:
    Sep 13, 2018
    Last Update Posted:
    Jan 28, 2019
    Last Verified:
    Jan 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Memantine

    Study Results

    No Results Posted as of Jan 28, 2019