Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Reformulated scopolamine patch · 1 trial · 1 indication
The maximum observed post-dose concentration.
The area under the plasma concentration versus time curve will be calculated from time 0 to infinity.
The area under the plasma concentration versus time curve will be calculated from time 0 to the last measurable sampling time point, t.
The time of the maximum observed post-dose concentration.
The terminal elimination rate constant.
Percentage of AUC0-inf obtained by extrapolation.
The elimination half-life.
Patch adherence evaluation will be performed.
| Arm | Type | Description |
|---|---|---|
| Reformulated scopolamine patch | EXPERIMENTAL | Participants will receive reformulated scopolamine Transdermal Delivery System (TDS) patch 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area with delivery of approximately 1.0 mg over 72 hours. |
| Marketed scopolamine patch | ACTIVE_COMPARATOR | Participants will receive currently marketed scopolamine TDS patch 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area, with delivery of approximately 1.0 mg over 72 hours. |
| Name | Type | Description |
|---|---|---|
| Reformulated scopolamine patch | DRUG | Reformulated scopolamine patch of 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area with deliver approximately 1.0 mg over 72 hours |
| Marketed scopolamine patch | DRUG | Marketed scopolamine patch of 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area with delivery of approximately 1.0 mg over 72 hours. |
Inclusion Criteria: * Participants must understand and provide written informed consent before any assessment is performed, understand the study procedures, and be willing and able to complete the required assessments. * Male or female participants of any ethnic origin, and aged from 18 to 55 years...
The reformulated scopolamine patch is used for motion sickness. It is a small molecule drug delivered through a transdermal delivery system. The patch is currently in Phase 1 clinical development and is being studied in healthy adult participants to evaluate its bioavailability and adhesion performance compared to an established reference transdermal system.
The reformulated scopolamine patch is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the patch's performance in treating motion sickness. The drug is currently in Phase 1 development, with one completed clinical trial involving 128 participants.
The reformulated scopolamine patch is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, which studied the patch's bioavailability and adhesion performance in healthy adult participants for the treatment of motion sickness.
The reformulated scopolamine patch has one completed clinical trial, NCT02839135. This Phase 1 study, titled 'A Comparative Bioavailability and Adhesion Performance Study, Comparing a New Scopolamine Transdermal Delivery System Formulation to the Currently Established Reference Transdermal Delivery System in Healthy Adult Participants,' enrolled 128 participants in Canada. The trial was active-controlled and randomized.
The reformulated scopolamine patch is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied for motion sickness, and one clinical trial has been completed to evaluate its bioavailability and adhesion performance compared to a reference transdermal delivery system.