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

Phase 1

Completed

• Conditions: Psychosis
• Interventions: Drug: Haloperidol 10 mg Tablets (Cord Laboratories); Drug: Haldol 10 mg Tablets (McNeil Pharmaceuticals)

• Registration Number: NCT00946491
• Lead Sponsor: Sandoz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1987-04
• Primary Completion: 1987-05
• Study Completion: 1987-05
• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Haloperidol 10 mg Tablets (Cord Laboratories)	Haloperidol 10 mg Tablets (Cord Laboratories)
2	Haldol 10 mg Tablets (McNeil Pharmaceuticals)	Haldol 10 mg Tablets (McNeil Pharmaceuticals)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	17 days