Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Risperdal OD Tab · 1 trial · 1 indication
| 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 ...
Risperdal OD Tab is an orally disintegrating tablet formulation of risperidone developed by Johnson & Johnson, which trades under the ticker JNJ. It is a small molecule product studied in a Phase 1 bioequivalence trial in healthy volunteers. The specific therapeutic indication for this formulation is not publicly disclosed in the trial record.
Risperdal OD Tab is made by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The Phase 1 bioequivalence study of the 2mg tablet was conducted by Janssen Korea, a Johnson & Johnson affiliate, in healthy adult volunteers.
Risperdal OD Tab has been studied in Phase 1 clinical development. One Phase 1 trial has been completed and no trials are currently active. The completed study was a bioequivalence test comparing the 2mg orally disintegrating tablet, so the program remains at the early clinical stage.
Risperdal OD Tab has been evaluated in one completed Phase 1 trial, NCT02012049, titled Bioequivalence Test for Risperdal 2mg of Janssen Korea. The study enrolled 36 healthy volunteers aged 20 years and older, was randomized and controlled, and has completed. No trials of this formulation are currently active.
The Risperdal OD Tab bioequivalence trial, NCT02012049, was a Phase 1 randomized, controlled study in 36 healthy volunteers aged 20 years and older. It was not double blinded and did not use biomarker-based patient selection. The trial has completed, and no further trials of this formulation are currently active.