Rivastigmine Transdermal Patches Bioequivalence and Adhesion Assessment

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.