To Demonstrate the Relative Bioequivalency of Generic Haloperidol Tablets Versus Haldol in Normal Volunteers

An Open-Label, Single-Dose, Crossover Study to Determine the Bioequivalency of Generic Haloperidol Tablets vs. Haldol in Normal Volunteers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00946491

Enrollment

Registered

2009-07-27

Start date

1987-04-30

Completion date

1987-05-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis

Keywords

Typical Antipsychotic

Brief summary

To demonstrate the relative bioequivalency of generic Haloperidol tablets versus Haldol in normal volunteers.

Interventions

DRUGHaloperidol 10 mg Tablets (Cord Laboratories)

DRUGHaldol 10 mg Tablets (McNeil Pharmaceuticals)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

35 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on AUC and Cmax	17 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026