Back to resultsTo Demonstrate the Relative Bioequivalency of Generic Haloperidol Tablets Versus Haldol in Normal Volunteers
Primary Purpose
Psychosis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Haloperidol 10 mg Tablets (Cord Laboratories)
Haldol 10 mg Tablets (McNeil Pharmaceuticals)
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis focused on measuring Typical Antipsychotic
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Haloperidol 10 mg Tablets (Cord Laboratories)
Haldol 10 mg Tablets (McNeil Pharmaceuticals)
Outcomes
Primary Outcome Measures
Bioequivalence based on AUC and Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00946491
Brief Title
To Demonstrate the Relative Bioequivalency of Generic Haloperidol Tablets Versus Haldol in Normal Volunteers
Official Title
An Open-Label, Single-Dose, Crossover Study to Determine the Bioequivalency of Generic Haloperidol Tablets vs. Haldol in Normal Volunteers.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 1987 (undefined)
Primary Completion Date
May 1987 (Actual)
Study Completion Date
May 1987 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
To demonstrate the relative bioequivalency of generic Haloperidol tablets versus Haldol in normal volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
Typical Antipsychotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Haloperidol 10 mg Tablets (Cord Laboratories)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Haldol 10 mg Tablets (McNeil Pharmaceuticals)
Intervention Type
Drug
Intervention Name(s)
Haloperidol 10 mg Tablets (Cord Laboratories)
Intervention Type
Drug
Intervention Name(s)
Haldol 10 mg Tablets (McNeil Pharmaceuticals)
Primary Outcome Measure Information:
Title
Bioequivalence based on AUC and Cmax
Time Frame
17 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip T. Leese, M.D.
Organizational Affiliation
Quincy Research Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
To Demonstrate the Relative Bioequivalency of Generic Haloperidol Tablets Versus Haldol in Normal Volunteers
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