NCT07464340

Rivastigmine Transdermal Patches Bioequivalence and Adhesion Assessment

Bioequivalence and Adhesion Assessment Between Two Rivastigmine Transdermal Patch Formulations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Zodiac Produtos Farmaceuticos S.A. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioequivalence Study in Healthy Subjects

Interventions

Type	Name	Description
DRUG	Rivastigmine TDS 9,5 mg/24 h	Rivastigmine Transdermal Patch
DRUG	Exelon® 9.5 mg/24 h	Exelon Patch 10

Timeline

• Start date: 2023-05-12
• Primary completion: 2023-06-06
• Completion: 2023-07-03
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: Brazil