Bioequivalence Study in Healthy Subjects
Conditions
Brief 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.
Interventions
DRUGRivastigmine TDS 9,5 mg/24 h
Rivastigmine Transdermal Patch
Exelon Patch 10
Sponsors
Zodiac Produtos Farmaceuticos S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC12-t | 12 to 48 hours after patch application | Area under the plasma concentration-time curve of rivastigmine from 12 hours to the last quantifiable concentration. |
| Patch Adhesion | 24 hours after patch application | Percentage of the transdermal patch surface remaining adhered to the skin at the end of the 24-hour dosing interval. |
| Cmax | Up to 48 hours after patch application | Maximum observed plasma concentration of rivastigmine following application of the transdermal patch. |
| AUC0-t | Up to 48 hours after patch application | Area under the plasma concentration-time curve from time zero to the last quantifiable concentration of rivastigmine. |
| AUC0-12 | 0 to 12 hours after patch application | Area under the plasma concentration-time curve of rivastigmine from time zero to 12 hours after patch application. |
Countries
Brazil
Outcome results
None listed