Bioequivalence Study in Healthy SubjectsPhase 1NCT07464340
Rivastigmine Transdermal Patches Bioequivalence and Adhesion Assessment
A Phase 1 study testing Rivastigmine TDS 9,5 mg/24 h and Exelon® 9.5 mg/24 h in people with Bioequivalence Study in Healthy Subjects, run by Zodiac Produtos Farmaceuticos S.A. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study in Healthy Subjects
- What is being tested?
- Rivastigmine TDS 9,5 mg/24 h and Exelon® 9.5 mg/24 h
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- 12 May 2023to 3 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Ciências Farmacêuticas de Estudos e Pesquisas
Aparecida de Goiânia, Goiás, 74935-530
About this study
Official title: 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.
- Conditions
- Bioequivalence Study in Healthy Subjects
- Being tested
- Rivastigmine TDS 9,5 mg/24 h, Exelon® 9.5 mg/24 h
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivastigmine TDS 9,5 mg/24 hDrug
Rivastigmine Transdermal Patch
Exelon® 9.5 mg/24 hDrug
Exelon Patch 10
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Single application of the test rivastigmine transdermal patch (9.5 mg/24 h) for a 24-hour wear period. Receives: 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. Receives: Drug: Exelon® 9.5 mg/24 h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration of rivastigmine following application of the transdermal patch.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours after patch application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start12 May 2023
- Primary completion6 Jun 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bioequivalence Study in Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zodiac Produtos Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464340
- Sponsor's protocol ID
- PBIO03222
- Status last verified
- Aug 2023
- First submitted
- 6 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to confidentiality restrictions and institutional policies regarding participant-level clinical data.
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, Pommier F, Sedek G, Allison M, Huang HL, Kiese B, Ho YY, Appel-Dingemanse S. Pharmacokinetics and bioavailability of the novel rivastigmine transdermal patch versus rivastigmine oral solution in healthy elderly subjects. J Clin Pharmacol. 2008 Feb;48(2):246-52. doi: 10.1177/0091270007312154. No abstract available.
PubMed 18199897Hossain M, Jhee SS, Shiovitz T, McDonald C, Sedek G, Pommier F, Cutler NR. Estimation of the absolute bioavailability of rivastigmine in patients with mild to moderate dementia of the Alzheimer's type. Clin Pharmacokinet. 2002;41(3):225-34. doi: 10.2165/00003088-200241030-00006.
PubMed 11929322
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence and Adhesion Assessment Between Two Rivastigmine Transdermal Patch Formulations
- ClinicalTrials.gov ID
- NCT07464340
- Acronym / sponsor ID
- PBIO03222
- Conditions
- Bioequivalence Study in Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Zodiac Produtos Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- 12 May 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Rivastigmine TDS 9,5 mg/24 hSingle application of the test rivastigmine transdermal patch (9.5 mg/24 h) for a 24-hour wear period. |
| Comparator | Active comparator | Drug: Exelon® 9.5 mg/24 hSingle application of the reference rivastigmine transdermal patch (Exelon® Patch 10, 9.5 mg/24 h) for a 24-hour wear period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivastigmine TDS 9,5 mg/24 hRivastigmine Transdermal Patch | Drug | Test |
| Exelon® 9.5 mg/24 hExelon Patch 10 | Drug | Comparator |
Primary outcome
Cmax
Time frame: Up to 48 hours after patch application
Maximum observed plasma concentration of rivastigmine following application of the transdermal patch.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- BackgroundBRASIL. 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: PubMed 18199897Lefevre G, Pommier F, Sedek G, Allison M, Huang HL, Kiese B, Ho YY, Appel-Dingemanse S. Pharmacokinetics and bioavailability of the novel rivastigmine transdermal patch versus rivastigmine oral solution in healthy elderly subjects. J Clin Pharmacol. 2008 Feb;48(2):246-52. doi: 10.1177/0091270007312154. No abstract available.
- Background: PubMed 11929322Hossain M, Jhee SS, Shiovitz T, McDonald C, Sedek G, Pommier F, Cutler NR. Estimation of the absolute bioavailability of rivastigmine in patients with mild to moderate dementia of the Alzheimer's type. Clin Pharmacokinet. 2002;41(3):225-34. doi: 10.2165/00003088-200241030-00006.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to confidentiality restrictions and institutional policies regarding participant-level clinical data.
Related trials for Bioequivalence Study in Healthy Subjects
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
Healthy Subjects (HS)
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
RecruitingPhase 1
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
Healthy
RecruitingPhase 1
A Phase 1 Study of Navlimetostat Tablet Formulations
Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rivastigmine TDS 9,5 mg/24 h and Exelon® 9.5 mg/24 h in people with Bioequivalence Study in Healthy Subjects, run by Zodiac Produtos Farmaceuticos S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Up to 48 hours after patch application). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07464340, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.