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NCT00946491 Clinical Trial

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

Psychosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00946491
Other study ID # 87-01
Secondary ID
Status Completed
Phase Phase 1
First received July 24, 2009
Last updated March 27, 2017
Start date April 1987
Est. completion date May 1987

Study information
Verified date July 2009
Source Sandoz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date May 1987
Est. primary completion date May 1987
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 35 Years to 55 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Haloperidol 10 mg Tablets (Cord Laboratories)

• Haldol 10 mg Tablets (McNeil Pharmaceuticals)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sandoz

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence based on AUC and Cmax 17 days
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