Generic Alzheimer's patch put to the test in healthy volunteers
NCT ID NCT07464340
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study checked whether a new generic rivastigmine patch works as well as the brand-name Exelon® patch. Sixty-eight healthy adults wore each patch to compare how much medicine got into their blood and how well the patch stuck to the skin. The goal was to see if the generic version is a good alternative, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rivastigmine transdermal patch
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
68 people
The number who actually took part.
- Started
-
May 2023
- Finished
-
Jul 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. * Consumption of grapefruit-containing products, alcohol, or substances that could interfere with drug metabolism prior to dosing. * Use of medications known to significantly affect hepatic metabolism. * Dermatological conditions or skin alterations that could interfere with patch adhesion or drug absorption. * Positive or suspected infection with SARS-CoV-2 prior to study periods. * Any condition that, in the investigator's judgment, could interfere with study participation or the interpretation of study results.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Instituto de Ciências Farmacêuticas de Estudos e Pesquisas
Aparecida de Goiânia, Goiás, 74935-530, Brazil
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