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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02012049 | Bioequivalence Test for Risperdal 2mg of Janssen Korea | PHASE1 | COMPLETED | 36 | — | — | Aug 1, 2009 | Aug 1, 2009 | Dec 16, 2013 | - | — |
| Arm | Type | Description |
|---|---|---|
| Risperdal OD / Risperdal Quicklet | EXPERIMENTAL | Risperdal OD (investigational drug) + Risperdal Quicklet (control drug) |
| Risperdal Quicklet / Risperdal OD | EXPERIMENTAL | Risperdal Quicklet (control drug) + Risperdal OD (investigational drug) |
| Name | Type | Description |
|---|---|---|
| Risperdal OD Tab. 2mg | DRUG | 1 tablet Risperdal OD 2 mg administered orally. |
| Risperdal Quicklet Tab. 2mg | DRUG | 1 tablet Risperdal Quicklet Tab. 2mg administered orally. |
Inclusion Criteria: * Healthy Korean participants weighing more than 50kg and within 20% normal lean body weight (standard weight) * Participant without congenital or chronic diseases and with no symptoms or findings as a result of internal examination * Participant who was deemed appropriate as a ...