clinical trial · NCT07464340
Rivastigmine Transdermal Patches Bioequivalence and Adhesion Assessment
Zodiac Produtos Farmaceuticos S.A.·phase1·completed·n = 68
Bioequivalence Study in Healthy SubjectsRivastigmine TDS 9,5 mg/24 hExelon® 9.5 mg/24 h
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.
started
May 12, 2023
primary completion
Jun 6, 2023
completion
Jul 3, 2023
last updated
Mar 11, 2026
official title
Bioequivalence and Adhesion Assessment Between Two Rivastigmine Transdermal Patch Formulations
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol