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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Psychosis

Treatments: Drug: Haldol 10 mg Tablets (McNeil Pharmaceuticals); Drug: Haloperidol 10 mg Tablets (Cord Laboratories)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00946491

87-01

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 35 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

1

Experimental group

Description:

Haloperidol 10 mg Tablets (Cord Laboratories)

Treatment:

Drug: Haloperidol 10 mg Tablets (Cord Laboratories)

2

Active Comparator group

Description:

Haldol 10 mg Tablets (McNeil Pharmaceuticals)

Treatment:

Drug: Haldol 10 mg Tablets (McNeil Pharmaceuticals)