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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00650117 | Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System | PHASE1 | COMPLETED | 12 | — | — | Oct 1, 2006 | Oct 1, 2006 | Apr 23, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M) |
| 2 | EXPERIMENTAL | Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M) |
| 3 | EXPERIMENTAL | Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M) |
| 4 | EXPERIMENTAL | Duragesic 25 mcg/h + Scotch Duct Tape (3M) |
| 5 | EXPERIMENTAL | Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M) |
| 6 | EXPERIMENTAL | Duragesic 25 mcg/h + Microfoam Tape (3M) |
| Name | Type | Description |
|---|---|---|
| Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M) | DRUG | single application |
| Duragesic 25 mcg/h + Scotch Duct Tape (3M) | DRUG | single application |
| Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M) | DRUG | single application |
| Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M) | DRUG | single application |
| Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M) | DRUG | single application |
| Duragesic 25 mcg/h + Microfoam Tape (3M) | DRUG | single application |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 21 days prior to the start of the study and on the ev...