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Study Comparing Bioavailability of Oral Formulations of Vabicaserin

Last updated on November 6, 2019

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Study Location
Philadelphia, Pennsylvania, 19148 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy men aged 18-50 years.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Any significant disease state.

- History of drug or alcohol abuse within 1 year.

- Abnormal liver function tests.

NCT00541996
Pfizer
Completed
Study Comparing Bioavailability of Oral Formulations of Vabicaserin

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Descriptive Information
Brief Title  ICMJE Study Comparing Bioavailability of Oral Formulations of Vabicaserin
Official Title  ICMJE A Randomized, Open-Label, Single-Dose, 4-Period Crossover, Comparative Bioavailability Study of 3 Sustained- Release Formulations and an Immediate- Release Formulation of Vabicaserin (SCA-136) in Healthy Subjects
Brief SummaryThe purpose of this study is to determine the absorption rate of four oral formulations of vabicaserin.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: vabicaserin
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy men aged 18-50 years.

Exclusion Criteria:

  • Any significant disease state.
  • History of drug or alcohol abuse within 1 year.
  • Abnormal liver function tests.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00541996
Other Study ID Numbers  ICMJE 3153A1-1116
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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