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OpenTrials
Completed

NCT Number: NCT00946491

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

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

Completed

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Key information

Conditions

Psychosis Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

35 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Haloperidol 10 mg Tablets (Cord Laboratories)

Drug

Haldol 10 mg Tablets (McNeil Pharmaceuticals)

Drug

Primary outcomes

  1. Bioequivalence based on AUC and Cmax

    Time frame: 17 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

An Open-Label, Single-Dose, Crossover Study to Determine the Bioequivalency of Generic Haloperidol Tablets vs. Haldol in Normal Volunteers.

Important dates

Study start
1987
Primary completion
1987
Study completion
1987
First posted
Jul 27, 2009
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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