NCT03670095

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Lactose-free memantine	Lactose-free memantine tablet, 10 mg; orally as a single dose
DRUG	Memantine	Lactose-containing memantine tablet, 10 mg, orally as a single dose

Timeline

• Start date: 2018-08-28
• Primary completion: 2018-12-24
• Completion: 2018-12-24
• First posted: 2018-09-13
• Last updated: 2024-02-29

Locations

1 site across 1 country: China