Rivastigmine Transdermal Patches Bioequivalence and Adhesion Assessment

March 10, 2026 updated by: Zodiac Produtos Farmaceuticos S.A.

Bioequivalence and Adhesion Assessment Between Two Rivastigmine Transdermal Patch Formulations

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Goiás
      • Aparecida de Goiânia, Goiás, Brazil, 74935-530
        • Instituto de Ciências Farmacêuticas de Estudos e Pesquisas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test
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
Rivastigmine Transdermal Patch
Active Comparator: 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
Exelon Patch 10

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Up to 48 hours after patch application
Maximum observed plasma concentration of rivastigmine following application of the transdermal patch.
Up to 48 hours after patch application
AUC0-t
Time Frame: Up to 48 hours after patch application
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
Time Frame: 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.
0 to 12 hours after patch application
AUC12-t
Time Frame: 12 to 48 hours after patch application
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
Time Frame: 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.
24 hours after patch application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zodiac Produtos Farmaceuticos S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
  • 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.
  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PBIO03222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to confidentiality restrictions and institutional policies regarding participant-level clinical data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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