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

Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psychosis

Intervention: Haloperidol 10 mg Tablets (Cord Laboratories) (Drug); Haldol 10 mg Tablets (McNeil Pharmaceuticals) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sandoz Inc.

Official(s) and/or principal investigator(s):
Philip T. Leese, M.D., Principal Investigator, Affiliation: Quincy Research Center

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence based on AUC and Cmax

Eligibility

Minimum age: 35 Years. Maximum age: 55 Years. Gender(s): Male.

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.

Locations and Contacts

Additional Information

Starting date: April 1987
Last updated: July 24, 2009

Page last updated: August 23, 2015

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