Rivastigmine Transdermal Patches Bioequivalence and Adhesion Assessment

NCT07464340 | Completed Phase 1

• 1 other identifier: PBIO03222
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioequivalence Study in Healthy Subjects

Outcome Measures

Primary Outcomes (5)

• Cmax

  Maximum observed plasma concentration of rivastigmine following application of the transdermal patch.

  Up to 48 hours after patch application

• AUC0-t

  Area under the plasma concentration-time curve from time zero to the last quantifiable concentration of rivastigmine.

  Up to 48 hours after patch application

• AUC0-12

  Area under the plasma concentration-time curve of rivastigmine from time zero to 12 hours after patch application.

  0 to 12 hours after patch application

• AUC12-t

  Area under the plasma concentration-time curve of rivastigmine from 12 hours to the last quantifiable concentration.

  12 to 48 hours after patch application

• Patch Adhesion

  Percentage of the transdermal patch surface remaining adhered to the skin at the end of the 24-hour dosing interval.

  24 hours after patch application

Study Arms (2)

Test

EXPERIMENTAL

Single application of the test rivastigmine transdermal patch (9.5 mg/24 h) for a 24-hour wear period.

Drug: Rivastigmine TDS 9,5 mg/24 h

Comparator

ACTIVE COMPARATOR

Single application of the reference rivastigmine transdermal patch (Exelon® Patch 10, 9.5 mg/24 h) for a 24-hour wear period.

Drug: Exelon® 9.5 mg/24 h

Interventions

Rivastigmine TDS 9,5 mg/24 h DRUG

Rivastigmine Transdermal Patch

Test

Exelon® 9.5 mg/24 h DRUG

Exelon Patch 10

Comparator

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zodiac Produtos Farmaceuticos S.A.: lead

Study Sites (1)

Instituto de Ciências Farmacêuticas de Estudos e Pesquisas

Aparecida de Goiânia, Goiás, 74935-530, Brazil

Location

Related Publications (3)

• BRASIL. AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA. Resolução - RDC nº 742, de 10 de agosto de 2022. "DISPÕE SOBRE OS CRITÉRIOS PARA CONDUÇÃO DE ESTUDOS DE BIODISPONIBILIDADE RELATIVA/BIOEQUIVALÊNCIA (BD/BE) E ESTUDOS FARMACOCINÉTICOS". Diário Oficial da União, Brasília, 17 de agosto de 2022.

  BACKGROUND

• Lefevre, G. et al. Pharmacokinetics and Bioavailability of the Novel Rivastigmine transdermal patch versus rivastigmine oral solution in healthy elderly subjects. J. Clin. Pharmacol., v. 48, p.246-252, 2008.

  BACKGROUND

• Hossain, M. et al. Estimation of the Absolute Bioavailability of Rivastigmine in Patients with Mild to Moderate Dementia of the Alzheimer's Type. Clin Pharmacokinet, v. 41, n.3, p. 225-234, 2002.

  BACKGROUND

MeSH Terms

Interventions

Rivastigmine

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 11, 2026
• Study Start: May 12, 2023
• Primary Completion: June 6, 2023
• Study Completion: July 3, 2023
• Last Updated: March 11, 2026

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)