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

NCT ID: NCT03670095

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2018-12-24

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lactose-free memantine tablet

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

Group Type: EXPERIMENTAL

Lactose-free memantine

Intervention Type: DRUG

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

Lactose-containing memantine tablet (Ebixa®)

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

Group Type: EXPERIMENTAL

Memantine

Intervention Type: DRUG

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

Interventions

Lactose-free memantine

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

Intervention Type: DRUG

Memantine

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

Intervention Type: DRUG

Other Intervention Names

Ebixa®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

Shuguang Hospital, Shanghai TCM University

Shanghai, , China

Countries

China

Other Identifiers

17773A

Identifier Type: -

Identifier Source: org_study_id