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Risperdal OD Tab

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Dec 16, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Risperdal OD Tab · 1 trial · 1 indication

Phase 1 1
NCT02012049Bioequivalence Test for Risperdal 2mg of Janssen KoreaHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
Bioequivalence Test for Risperdal 2mg of Janssen Korea
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Study Endpoints

Primary Endpoints

Plasma concentrations of Risperidone
Up to 24 hours postdose

Secondary Endpoints

Number of participants with adverse events as a measure of safety
Approximately 10 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Risperdal OD / Risperdal QuickletEXPERIMENTALRisperdal OD (investigational drug) + Risperdal Quicklet (control drug)
Risperdal Quicklet / Risperdal ODEXPERIMENTALRisperdal Quicklet (control drug) + Risperdal OD (investigational drug)

Interventions

NameTypeDescription
Risperdal OD Tab. 2mgDRUG1 tablet Risperdal OD 2 mg administered orally.
Risperdal Quicklet Tab. 2mgDRUG1 tablet Risperdal Quicklet Tab. 2mg administered orally.
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Eligibility Criteria

Age Range20 Years to 55 Years
SexALL
Healthy VolunteersYes

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 ...

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Frequently asked questions about Risperdal OD Tab

What is Risperdal OD Tab used for?

Risperdal OD Tab is an orally disintegrating tablet formulation of risperidone being developed by Johnson & Johnson. In the clinical trial data available, it was studied in healthy volunteers to assess bioequivalence of the 2 mg dose. The drug is a small molecule therapeutic.

Who makes Risperdal OD Tab?

Risperdal OD Tab is developed by Johnson & Johnson, which trades under the ticker JNJ. The company conducted a bioequivalence study for the 2 mg formulation of Risperdal OD Tab in healthy volunteers.

What phase is Risperdal OD Tab in?

Risperdal OD Tab is in Phase 1 clinical development. One Phase 1 trial has been completed, which evaluated the bioequivalence of the 2 mg dose in healthy volunteers. The drug is investigational and not yet approved.

What clinical trials is Risperdal OD Tab in?

Risperdal OD Tab has one completed clinical trial, NCT02012049, titled 'Bioequivalence Test for Risperdal 2mg of Janssen Korea.' This Phase 1 study enrolled 36 healthy volunteers aged 20 years and older, with no double-blind design and a controlled study type.

Is Risperdal OD Tab the same as risperidone?

Risperdal OD Tab is an orally disintegrating tablet formulation of risperidone, an antipsychotic medication. The 'OD' in the name indicates the orally disintegrating dosage form, which dissolves in the mouth without water. The active ingredient is risperidone.