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Also known as Rotigotine Transdermal Delivery System (TDS)
Rotigotine Delivery System · 1 trial · 3 indications
Peak Plasma Concentration (Cmax) 90% confidence limits of T/R ratio must lie within 80-125 %
The Test patch adhesion 90% LCL must lie above 90%.
The area under the plasma concentration versus time curve (AUC 0-t) 90% confidence limits of T/R ratio must lie within 80-125 %
The area under the plasma concentration versus time curve extrapolated to infinite (AUC i) 90% confidence limits of T/R ratio must lie within 80-125 %
| Arm | Type | Description |
|---|---|---|
| Test / Reference | OTHER | Rotigotina B7 TDS (Test) / Neupro® (Reference) |
| Reference / Test | OTHER | Neupro® (Reference) / Rotigotina B7 TDS (Test) |
| Name | Type | Description |
|---|---|---|
| Rotigotine Transdermal Delivery System (TDS) | COMBINATION_PRODUCT | Strength: 2 mg/24 hours |
Inclusion Criteria: 1. Age: 18 to 55 years old, both inclusive. 2. Gender: Male and/or non-pregnant, non-lactating female. A. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to first patch applicatio...
Rotigotine Delivery System is an investigational transdermal patch formulation of rotigotine, a small molecule drug candidate developed by Amarin Corporation plc. It is designed to deliver rotigotine through the skin. The program is in Phase 1 clinical development, and the specific therapeutic indication being pursued has not been disclosed.
Rotigotine Delivery System delivers rotigotine, which acts as an agonist at the dopamine receptors DRD2, DRD3, and DRD4. By activating these dopamine receptor subtypes, the drug mimics the action of endogenous dopamine. This receptor agonist target class is the basis for the patch's pharmacological activity.
Amarin Corporation plc, which trades on the Nasdaq under the ticker AMRN, is the developer of the Rotigotine Delivery System. The company is advancing this transdermal rotigotine patch as part of its clinical pipeline.
Rotigotine Delivery System is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The program has completed one Phase 1 trial, and no trials are currently active.
Rotigotine Delivery System has been studied in one completed Phase 1 trial, NCT07769359, titled Bioequivalence and Adhesion of a Rotigotine Patch in Healthy Subjects. The trial enrolled 35 healthy adult volunteers in India and used a randomized, controlled design without blinding.
Yes, Rotigotine Delivery System is also known as Rotigotine Transdermal Delivery System (TDS). Both names refer to the same Amarin Corporation plc patch program that delivers rotigotine through the skin.