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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Memantine; Drug: Lactose-free memantine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03670095

17773A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Lactose-free memantine tablet

Experimental group

Description:

(treatment A - test) - 10 mg; orally as a single dose in fed and fasted state

Treatment:

Drug: Lactose-free memantine

Lactose-containing memantine tablet (Ebixa®)

Experimental group

Description:

(treatment B - reference) - 10 mg, orally as a single dose in fed and fasted state

Treatment:

Drug: Memantine