Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 a small molecule drug being developed for bioequivalence, meaning it is intended to match the performance of an existing rotigotine patch. It is an investigational product studied in healthy volunteers to assess bioequivalence, adhesion, and adverse effects. It is not approved and remains in clinical development.
Rotigotine Delivery System is being developed by Amarin Corporation plc, a biopharmaceutical company traded on the NASDAQ under the ticker AMRN. The company is conducting clinical trials for this investigational rotigotine patch product.
Rotigotine Delivery System is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The Phase 1 trial has been completed, and the product remains under study for bioequivalence.
Rotigotine Delivery System has one completed Phase 1 trial, NCT07769359, titled "Bioequivalence and Adhesion of a Rotigotine Patch in Healthy Subjects." The study enrolled 35 healthy volunteers in India, aged 18 years and older, and assessed bioequivalence, adhesion, and adverse effects.
Rotigotine Delivery System is a rotigotine patch formulation intended to be bioequivalent to an existing rotigotine product. It delivers the same active ingredient, rotigotine, but is a distinct delivery system under development by Amarin Corporation plc. The trial evaluates its bioequivalence and adhesion.