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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03327558 | Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects | PHASE1 | COMPLETED | 60 | — | — | May 15, 2017 | Aug 18, 2017 | May 8, 2018 | 1 | United States |
Maximum observed plasma concentration levels used for descriptive analysis
| Arm | Type | Description |
|---|---|---|
| Apriso 0.375G ER CAP | EXPERIMENTAL | Apriso 0.375G ER Cap |
| APRISO 375 mg extended-release capsules | ACTIVE_COMPARATOR | APRISO 375 mg ER cap |
| Name | Type | Description |
|---|---|---|
| Apriso 0.375G ER CAP | DRUG | ER capsule |
| APRISO 375 mg extended-release capsules | DRUG | 375 mg extended-release capsules |
Inclusion Criteria: * Healthy male or female, at least 18 years of age * Body mass index (BMI) between18.5 and below 32.0 kg/m2 (inclusive) * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, ECG and labo...