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Study Determining Gastric-Retentive and Modified Release Properties of Prototype Capsules in Healthy Subjects

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

Clinical Trial Summary

To assess how long modified release (MR) memantine hydrochloride prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03468543
Study type Interventional
Source Lyndra Inc.
Contact
Status Terminated
Phase Early Phase 1
Start date July 26, 2017
Completion date September 18, 2017
View Details
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