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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03051685 | Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy Adults | PHASE1 | COMPLETED | 16 | — | — | Jul 20, 2015 | Nov 10, 2015 | Feb 13, 2018 | 1 | United States |
DFN-15 maximum Plasma Concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| DFN-15 Dose 1 | EXPERIMENTAL | - |
| DFN-15 Dose 2 | EXPERIMENTAL | - |
| DFN-15 Dose 3 | EXPERIMENTAL | - |
| Active Comparator | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DFN-15 Dose 1 | DRUG | - |
| DFN-15 Dose 2 | DRUG | - |
| DFN-15 Dose 3 | DRUG | - |
| Active Comparator | DRUG | - |
Inclusion Criteria: Subjects were male or female, at least 18 years of age but not older than 45 years of age. The main inclusion criteria were: 1. non- or ex-smokers 2. body mass index (BMI) ≥18.50 kg/m2 and \<30.00 kg/m2 3. no clinically significant abnormality found in the 12-lead ECG performed...