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

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ClinicalTrials.gov Identifier: NCT00946491
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

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

Condition or disease Intervention/treatment Phase
Psychosis Drug: Haloperidol 10 mg Tablets (Cord Laboratories) Drug: Haldol 10 mg Tablets (McNeil Pharmaceuticals) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose, Crossover Study to Determine the Bioequivalency of Generic Haloperidol Tablets vs. Haldol in Normal Volunteers.
Study Start Date : April 1987
Actual Primary Completion Date : May 1987
Actual Study Completion Date : May 1987

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Haloperidol 10 mg Tablets (Cord Laboratories)
Drug: Haloperidol 10 mg Tablets (Cord Laboratories)
Active Comparator: 2
Haldol 10 mg Tablets (McNeil Pharmaceuticals)
Drug: Haldol 10 mg Tablets (McNeil Pharmaceuticals)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 17 days ]


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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946491


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Philip T. Leese, M.D. Quincy Research Center

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946491     History of Changes
Other Study ID Numbers: 87-01
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: July 2009

Keywords provided by Sandoz:
Typical Antipsychotic

Additional relevant MeSH terms:
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents