CompletedPhase 1

Rivastigmine Transdermal Patches Bioequivalence and Adhesion Assessment

Brazil68 participantsStarted 2023-05-12

Plain-language summary

This study evaluates the bioequivalence and adhesion performance of a test rivastigmine transdermal patch compared with the reference product, Exelon® Patch 10 (9.5 mg/24 h), in healthy adult volunteers of both sexes under fasting conditions. The pharmacokinetic profiles will be compared to assess whether the test product demonstrates equivalent rate and extent of absorption to the reference formulation. Patch adhesion will also be evaluated throughout the dosing interval to determine whether the test product shows high adhesion (\>90%) or non-inferior adhesion compared with the reference product.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Body mass index (BMI) between 18.5 and 30.0 kg/m². * Non-smokers or former smokers who stopped smoking at least 1 year prior to screening. * Clinically healthy based on medical history, physical examination, vital signs, ECG, and clinical laboratory tests. * Negative screening for HIV, hepatitis B, and hepatitis C. * Female participants must not be pregnant or breastfeeding and must have a negative pregnancy test. * No hair, wounds, or dermatological conditions at the intended patch application site (upper arm). * Able to understand the study procedures and provide written informed consent Exclusion Criteria: * History or presence of clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, metabolic, pulmonary, or dermatological diseases. * Known hypersensitivity to rivastigmine, carbamate derivatives, or any component of the study formulation. * Abnormal clinical laboratory results, vital signs, or ECG considered clinically significant by the investigator. * Positive test results for drugs of abuse, alcohol misuse, HIV, hepatitis B, or hepatitis C. * Use of prescription or non-prescription medications that could interfere with the study drug within a defined period prior to dosing, as determined by the investigator. * Participation in another clinical trial or exposure to an investigational drug within the previous 6 months. * Blood donation or significant blood loss within 3 months prior to the study. * Con…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cmax

Timeframe: Up to 48 hours after patch application

AUC0-t

Timeframe: Up to 48 hours after patch application

AUC0-12

Timeframe: 0 to 12 hours after patch application

AUC12-t

Timeframe: 12 to 48 hours after patch application

Patch Adhesion

Timeframe: 24 hours after patch application

Trial details

NCT IDNCT07464340

SponsorZodiac Produtos Farmaceuticos S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-06

View on ClinicalTrials.gov More Bioequivalence Study in Healthy Subjects trials