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Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules Containing Memantine Hydrochloride in Healthy Adults

NCT03711825 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-02-26

No results posted yet for this study

Summary

To assess how long memantine hydrochloride (HCl) (50 mg) extended release capsules stay in the stomach as determined by imaging assessment (MRI or abdominal ultrasound).

To evaluate the safety of a memantine HCl extended release capsule formulation

Conditions

  • Alzheimer Disease
  • Gastric Retention
  • Healthy

Interventions

DRUG

LYN-057

Administration of single dose of LYN-057 presented as extended release capsule containing 50 mg of memantine hydrochloride (HCl)

PROCEDURE

Imaging Assessment (MRI)

Imaging assessments \[MRI\] will be performed on specified days according to protocol

PROCEDURE

Imaging Assessment (U/S)

Imaging assessments (abdominal U/S) will be performed on specified days according to protocol

Sponsors & Collaborators

  • Lyndra Inc.

    lead INDUSTRY

Principal Investigators

  • Sepehr Shakib, MD · CMAX

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2018-10-01
Completion
2018-11-13

Countries

  • Australia

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 NCT03711825 on ClinicalTrials.gov