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Haldol

Phase 1

Psychosis | Small molecule | Psychiatry |Novartis AG|Last Updated: Mar 28, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Haldol · 1 trial · 1 indication

Phase 1 1
NCT00946491To Demonstrate the Relative Bioequivalency of Generic Haloperidol Tablets Versus Haldol in Normal VolunteersPsychosis
COMPLETED30 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioequivalency of Generic Haloperidol Tablets Versus Haldol in Normal Volunteers
PsychosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
17 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALHaloperidol 10 mg Tablets (Cord Laboratories)
2ACTIVE_COMPARATORHaldol 10 mg Tablets (McNeil Pharmaceuticals)

Interventions

NameTypeDescription
Haloperidol 10 mg Tablets (Cord Laboratories)DRUG -
Haldol 10 mg Tablets (McNeil Pharmaceuticals)DRUG -
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Eligibility Criteria

Age Range35 Years to 55 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

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Frequently asked questions about Haldol

What is Haldol used for?

Haldol is a small molecule used for psychosis. It is being developed by Novartis AG for this psychiatric condition. The drug is currently in Phase 1 clinical development, meaning it is still investigational and has not been approved for use.

Who makes Haldol?

Haldol is developed by Novartis AG, a company traded under the ticker NVS. The drug is a small molecule being studied for the treatment of psychosis. It is currently in Phase 1 clinical development.

What phase is Haldol in?

Haldol is in Phase 1 clinical development. It is an investigational drug being studied for psychosis. The drug has not been approved, and its safety and efficacy are still being evaluated in early-stage clinical trials.

What clinical trials is Haldol in?

Haldol has one completed clinical trial, NCT00946491, which was a Phase 1 study titled "To Demonstrate the Relative Bioequivalency of Generic Haloperidol Tablets Versus Haldol in Normal Volunteers." The trial enrolled 30 healthy male volunteers aged 35 years and older.

Is Haldol the same as haloperidol?

Haldol is the brand name for the drug haloperidol. The clinical trial NCT00946491 compared generic haloperidol tablets to Haldol to demonstrate bioequivalency. Both refer to the same active pharmaceutical ingredient.