Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Memantine HCl and Donepezil HCl Extended Release Capsules in Healthy Volunteers

Phase 1

Completed

• Conditions: Alzheimer Disease; Neurological - Alzheimer's disease

• Registration Number: ACTRN12619000571178
• Lead Sponsor: yndra Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-11
• Study Completion: 2019-06-11
• Last Update Posted: 14 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1) Healthy male and female participants
2) Body mass index of 18.0 to 30.0 kg/meters-squared
3) Suitable score for swallowing questionnaire
4) Demonstrate normal swallowing and gastrointestinal passage for capsules, as assessed while undergoing imaging studies
5) Must provide written informed consent

Exclusion Criteria

1) History of any drug or alcohol abuse in past 2 years
2) Current smokers and those who have smoked within the past 12 months
3) Individuals with clinically significant medical history related to the gastrointestinal tract and potential complications, thereof
4) Individuals with a positive test for HIV, hepatitis B or hepatitis C
5) Individuals who are contraindicated based on either memantine HCl or donepezil HCl
6) Serious adverse reaction or serious hypersensitivity to components of the study formulation or patency capsule
7) Individuals who have received any experimental agent within 30 days (or 5 half-lives), whichever is longer, prior to the date of dosing
8) Individuals with contraindication to MRI imaging
9) Individuals with functional constipation, irritable bowl or functional diarrhoea
10) Individuals with contraindications to elective X-ray based on known or expected radiation exposure

Study & Design

• Study Type: Interventional
• Study Design: Not specified