Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003718-35 | EudraCT Number | ||
| 1428riv22ct | Other Identifier | SocraTec R&D GmbH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| SocraTec R&D GmbH | OTHER |
| SocraMetrics GmbH | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The present clinical trial will be conducted in order to compare the bioavailability of rivastigmine and to assess bioequivalence at steady-state of the Test product RID-TDS 13.3 mg/24 h (Luye Pharma AG, Germany) and the marketed Reference product Exelon® 13.3 mg/24 h transdermales Pflaster (Novartis Pharma GmbH, Germany) after multiple patch applications. Each of both treatments will last for 11 days with a washout period of 14 days between the treatments.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RID-TDS 13.3 mg/24 h | Experimental | 3 consecutive applications of 1 patch (1st patch for 4 days, 2nd patch for 3 days, 3rd patch for 4 days) covering an 11-day period |
|
| Exelon® 13.3 mg/24 h | Active Comparator | 11 consecutive applications of 1 patch (each patch will be applied for 1 day) covering an 11-day period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RID-TDS 13.3 mg/24 h | Drug | 3 consecutive applications of 1 patch (1st patch for 4 days, 2nd patch for 3 days, 3rd patch for 4 days) covering an 11-day period |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC96-264 | partial area under the plasma concentration vs. time profile for the time interval 96-264 hours | from 96 to 264 hours after the first patch application |
| Cmax96-264 | maximum concentration in plasma during the nominal time interval 96-264 hours | from 96 to 264 hours after the first patch application |
| Ctau264 | trough concentration at the planned time point 264 h p.a. | 264 hours after the first patch application |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | descriptive evaluation of frequency and intensity, relationship to the IMP, action taken, outcome, seriousness, period and treatment | approximately 7 to 12 weeks, through study completion in case of follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juliane Koerner, MD | SocraTec R&D GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SocraTec R&D GmbH, Clinical Pharmacology Unit | Erfurt | Thuringia | 99084 | Germany |
Not provided
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® 13.3 mg/24 h | Drug | 11 consecutive applications of 1 patch (each patch will be applied for 1 day) covering an 11-day period |
|
| D009930 |
| Organic Chemicals |