At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Bioequivalence and Adhesion Assessment Between Two Rivastigmine Transdermal Patch Formulations
In Brief
A Phase 1 clinical trial evaluating Rivastigmine TDS 9,5 mg/24 h and Exelon® 9.5 mg/24 h for Bioequivalence Study in Healthy Subjects. Completed, enrolled 68 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Rivastigmine Transdermal Patch
Exelon Patch 10