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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000968-28 | EudraCT Number | ||
| C_30170_P1_16 | Other Identifier | Luye Pharma AG / Luye Supply AG |
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| Name | Class |
|---|---|
| SocraMetrics GmbH | INDUSTRY |
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The present clinical trial will be conducted to compare the bioavailability of rivastigmine and assess bioequivalence at steady-state of the Test product RIV-TDS 13.3 mg/24 h and the marketed Reference product Exelon® 13.3 mg/24 hours transdermal patch after multiple patch application. Each of both treatments will last 5 days.
This will be a single centre, open-label, randomised (order of treatments), balanced, 2-period, 2-sequence, cross-over trial with multiple applications of rivastigmine transdermal patches. There will be no wash-out, i.e. the first investigational patch application of the second study period will take place the day of the last investigational patch removal of the first study period (direct switch-over).
Prior to start of first treatment, there will be an adaptation phase with 4 consecutive applications of Exelon® 9.5 mg/24 hours transdermal patch over a period of 4 days (each patch will be applied for 24 hours). Following the removal of the last investigational patch in period II, there will be a post-treatment tapering phase with 2 consecutive applications of Exelon® 9.5 mg/24 hours transdermal patch over a period of 2 days (each patch will be applied for 24 hours).
Furthermore, during the adaptation phase, both study periods and the tapering phase, scopolamine transdermal patches will be applied as co-medication to attenuate effects of rivastigmine and reduce Adverse Events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIV-TDS 13.3 mg/24 h (Test) | Experimental | 5 consecutive patch applications of Test (each patch to be applied for 24 hours) |
|
| Exelon® 13.3 mg/24 hours transdermal patch (Reference) | Active Comparator | 5 consecutive patch applications of Reference (each patch to be applied for 24 hours) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIV-TDS 13.3 mg/24 h | Drug | 5 consecutive transdermal patch applications, each with a nominal release rate of 13.3 mg/24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tau,ss | Area under the plasma concentration vs. time curve at steady state for rivastigmine | from 0 to 24 hours following the 5th patch application |
| Ctau,ss | (Trough) minimum plasma concentration at the end of the dosing interval at steady state for rivastigmine | from 0 to 24 hours following the 5th patch application |
| Cmax,ss | Maximum plasma concentration within the dosing interval at steady state for rivastigmine | from 0 to 24 hours following the 5th patch application |
| Measure | Description | Time Frame |
|---|---|---|
| Patch adhesion | one-sided lower 90% confidence limit of mean adherence percentage at the end of the dosing interval of the 5th patch | from first investigational patch application until removal of the last investigational patch (approx. 10 days) |
| Skin irritation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SocraTec R&D GmbH, Clinical Pharmacology Unit | Erfurt | Thuringia | 99084 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35696054 | Derived | Morte A, Vaque A, Iniesta M, Schug B, Koch C, De la Torre R, Schurad B. Bioavailability Study of a Transdermal Patch Formulation of Rivastigmine Compared with Exelon in Healthy Subjects. Eur J Drug Metab Pharmacokinet. 2022 Jul;47(4):567-578. doi: 10.1007/s13318-022-00778-5. Epub 2022 Jun 13. |
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| ID | Term |
|---|---|
| D000068836 | Rivastigmine |
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Exelon® 13.3 mg/24 hours transdermal patch | Drug | 5 consecutive transdermal patch applications, each with a nominal release rate of 13.3 mg/24 hours |
|
frequency of scores for quantification of skin irritation per treatment and time point |
| from first investigational patch removal until last investigational patch removal (approx. 10 days) |
| Adverse events | descriptive evaluation of frequency and intensity, relationship to the IMP, action taken, outcome, seriousness, period and treatment | approximately 2 weeks, through study completion in case of follow-up |
| D009930 |
| Organic Chemicals |
| D004864 | Equipment and Supplies |