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

NCT03468543 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-06-05

Study results available
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Summary

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

Conditions

  • Gastric Retention
  • Healthy

Interventions

DRUG

Memantine Hydrochloride MR Prototype Capsule Formulation A

Memantine HCl MR capsule formulation will be administered orally in a single dose

DRUG

Memantine Hydrochloride MR Prototype Capsule Formulation B

Memantine HCl MR capsule formulation will be administered orally in a single dose

DRUG

Memantine Hydrochloride MR Prototype Capsule Formulation C

Memantine HCl MR capsule formulation will be administered orally in a single dose

DRUG

Memantine Hydrochloride MR Prototype Capsule Formulation D

Memantine HCl MR capsule formulation will be administered orally in a single dose

DRUG

Memantine Hydrochloride MR Prototype Capsule Formulation E

Memantine HCl MR capsule formulation will be administered orally in a single dose

PROCEDURE

Magnetic Resonance Imaging

MRI will be performed on specified days according to protocol

Sponsors & Collaborators

  • Lyndra Inc.

    lead INDUSTRY

Principal Investigators

  • Stuart Mair, MBChB, DRCOG · Quotient Clinical

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2017-09-18
Completion
2017-09-18

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03468543 on ClinicalTrials.gov