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Haldol

Phase 1

Psychosis | Small molecule | Psychiatry |Novartis AG|Trials 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

Haldol clinical trials

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?

Haldol is a small molecule drug developed by Novartis AG (ticker NVS) for psychosis in the psychiatry therapeutic area. It is also known as Haldol 10 mg Tablets (McNeil Pharmaceuticals). It is investigational and has been studied in a Phase 1 clinical trial.

What is Haldol used for?

Haldol is used for psychosis. It is being developed by Novartis AG (ticker NVS) for this indication. The drug is investigational and has been evaluated in a Phase 1 clinical trial.

Who makes Haldol?

Haldol is developed by Novartis AG, which trades under the ticker NVS. The drug is also known as Haldol 10 mg Tablets (McNeil Pharmaceuticals).

What phase is Haldol in?

Haldol is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed.

What clinical trials is Haldol in?

Haldol has been studied in one completed Phase 1 trial, NCT00946491, 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 and was active-controlled.