Healthy Clinical Trial
Official title:
A Study Designed to Determine the Gastro-Retentive and Modified Release Properties of Memantine Hydrochloride (HCl) Prototype Capsule Formulations in Healthy Subjects
To assess how long modified release (MR) memantine hydrochloride prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).
This is a single center, open-label, single dose, 5-period study in 24 healthy male and
female subjects, with an optional Period 6, if required. It is expected the study will be
executed in 3 cohorts of 8 subjects, with each cohort participating in up to 2 study periods
(total of up to 6 study periods). Cohort 3 may be conducted in parallel with Cohort 2.
Subjects will be dosed in a sequential manner, as appropriate. Each subject will be
administered up to 2 regimens (2 different prototype capsule formulations) across 2 study
periods. There will be a minimum 35-day interval between each dose administration.
Subjects will have an MRI scan performed on Days 2, 4, 7, 10 and 14 of each period to assess
the gastric retentive properties of the formulation.
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