Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02839135 | 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. | PHASE1 | COMPLETED | 128 | — | — | May 13, 2016 | Aug 10, 2016 | May 18, 2018 | 1 | Canada |
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...