NCT00946491

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 1987

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1987

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 1987

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1987

Completed
22.2 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

March 28, 2017

Status Verified

July 1, 2009

Enrollment Period

1 month

First QC Date

July 24, 2009

Last Update Submit

March 27, 2017

Conditions

Psychosis

Keywords

Typical Antipsychotic

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    17 days

Study Arms (2)

1

EXPERIMENTAL

Haloperidol 10 mg Tablets (Cord Laboratories)

Drug: Haloperidol 10 mg Tablets (Cord Laboratories)

2

ACTIVE COMPARATOR

Haldol 10 mg Tablets (McNeil Pharmaceuticals)

Drug: Haldol 10 mg Tablets (McNeil Pharmaceuticals)

Interventions

Haloperidol 10 mg Tablets (Cord Laboratories)DRUG
1
Haldol 10 mg Tablets (McNeil Pharmaceuticals)DRUG
2

Eligibility Criteria

Age35 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic Chemicals

Study Officials

  • Philip T. Leese, M.D.

    Quincy Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

April 1, 1987

Primary Completion

May 1, 1987

Study Completion

May 1, 1987

Last Updated

March 28, 2017

Record last verified: 2009-07