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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00946491
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 1987
Study Completion Date: May 1987
Primary Completion Date: May 1987 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00946491

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

No publications provided

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
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Typical Antipsychotic

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on July 22, 2014