Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single-Dose Memantine Hydrochloride and Donepezil Hydrochloride Extended Release Capsules in Healthy Volunteers

Phase 1

Recruiting

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

• Registration Number: ACTRN12619001566123
• Lead Sponsor: yndra Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-13
• Last Update Posted: 24 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1.Provision of signed and dated informed consent;
2.Stated willingness to comply with all protocol-specified procedures and availability for the duration of the study;
3.Good current health, in the opinion of the Investigator, as evidenced on review of medical history, no significant gastrointestinal abnormalities, physical examination, concomitant medications, and other safety assessments.
4..Body mass index (BMI) of greater than or equal to 18 kg/meters-squared and less than or equal to 30 kg/meters-squared
5.Body weight of greater than or equal to 55 kg;

Exclusion Criteria

1.Any known clinically significant oesophageal or gastrointestinal disease;
2.Unsuitable score for swallowing questionnaire;
3.Do not demonstrate normal swallowing and gastrointestinal passage for capsule, as assessed while undergoing imaging studies;
4.Symptoms suggestive of irritable bowel syndrome, functional constipation or functional diarrhoea;
5.History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs;
6.Clinically significant abnormal safety (e.g., physical examination) or safety laboratory assessments;
7.Active hepatitis B, hepatitis C, or H. pylori infection at Screening, unless there is a confirmed medical history of successful treatment;
8.Use of prescription medications, natural remedies, vitamins or non-prescription (over the counter) medicines associated with changes to gastric motility or pH or management of gastrointestinal symptoms within two weeks of study dosing;
9.Individuals who are contraindicated based on memantine HCl or donepezil HCl;
10.History of any drug or alcohol abuse in the past 2 years;
11.Individuals of reproductive potential who are (hetero) sexually active but unwilling to use acceptable means of contraception through the End of Study;
12.Individuals who are nursing or who have positive or indeterminate pregnancy test.

Study & Design

• Study Type: Interventional
• Study Design: Not specified