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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001570-18 | EudraCT Number | ||
| C_30410_P1_05 | 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 in order to compare the bioavailability of rivastigmine and to assess bioequivalence at steady-state of the Test product RID-TDS 9.5 mg/24 h (Luye Pharma AG, Germany) and the marketed Reference product Exelon® 9.5 mg/24 h transdermales Pflaster (Novartis Pharma GmbH, Germany) after multiple patch application. Each of both treatments will last for 11 days with a washout period of 14 days between the treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RID-TDS 9.5 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® 9.5 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 9.5 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 |
| Cmax,96-264 | maximum concentration in plasma during the nominal time interval 96-264 hours | from 96 to 264 hours after the first patch application |
| Cmin,96-264 | absolute minimum concentration within the nominal time interval 96-264 hours | from 96 to 264 hours after the first patch application |
| Patch adhesion properties | lower one-sided 90% confidence limit for the mean of Test | at 96, 168 and 264 hours after the first Test patch application |
| Measure | Description | Time Frame |
|---|---|---|
| Skin irritation | frequency of scores for quantification of skin irritation per treatment and time point | from first patch removal until last patch removal (approx. 9 to 13 days) |
| Adverse events |
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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 |
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| ID | Term |
|---|---|
| D000068836 | Rivastigmine |
| ID | Term |
|---|---|
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Exelon® 9.5 mg/24 h | Drug | 11 consecutive applications of 1 patch (each patch will be applied for 1 day) covering an 11-day period |
|
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 |
| inhibition of plasma butyrylcholinesterase (BuChE) | % inhibition of BuChE activity in plasma in comparison to baseline | from first patch application until 24 hours after the last patch removal |
| D009930 |
| Organic Chemicals |