Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Single application of the test rivastigmine transdermal patch (9.5 mg/24 h) for a 24-hour wear period. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine TDS 9,5 mg/24 h | Drug | Rivastigmine Transdermal Patch |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Ciências Farmacêuticas de Estudos e Pesquisas | Aparecida de Goiânia | Goiás | 74935-530 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 18199897 | Background | 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. | |
| 11929322 |
Not provided
Not provided
Individual participant data (IPD) will not be shared due to confidentiality restrictions and institutional policies regarding participant-level clinical data.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000068836 | Rivastigmine |
| ID | Term |
|---|---|
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Exelon® 9.5 mg/24 h |
| Drug |
Exelon Patch 10 |
|
| Background |
| Hossain 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. |
| D009930 |
| Organic Chemicals |