Study of Memantine Hydrochloride MR Prototype Capsules QCL117924
Research type
Research Study
Full title
A Study Designed to Determine the Gastro-Retentive and Modified Release Properties of Memantine Hydrochloride Prototype Capsule Formulations in Healthy Subjects
IRAS ID
223811
Contact name
Jacqueline Schumacher
Contact email
Sponsor organisation
Lyndra Inc.
Eudract number
2017-000982-61
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
The sponsor is developing a new gastro-retentive (GR) capsule which is designed to stay in the stomach safely for 7 to 10 days or longer, allowing slow, controlled release of a medicine.\n\nThe capsule will contain memantine hydrochloride, a marketed Alzheimer’s disease medication.\n\nThe study is designed to assess the impact of minor changes to the component parts of the GR capsule (the formulation) on the level of medicine in the blood, in order to improve its GR properties.\n\nThe study will consist of 5 periods, with an optional 6th period. Twenty-four healthy male and female volunteers are to be dosed in 3 cohorts of 8, with each volunteer participating in up to 2 single-dose study periods. Each dose will be 50 mg memantine hydrochloride and there will be at least 4 weeks between each dose the volunteer receives.\n\nEach volunteer will have blood samples taken to assess how much medicine is in the body and faecal samples will be collected in order to retrieve the competent parts of the capsule. Volunteers will also have MRI scans (5 planned per period) and abdominal X-rays (1 planned per period only if a volunteer has received a radiopaque formulation), in order to assess the GR properties of the capsule. \n
REC name
HSC REC B
REC reference
17/NI/0105
Date of REC Opinion
13 Jul 2017
REC opinion
Further Information Favourable Opinion