Text Size

Study Comparing Bioavailability of Oral Formulations of Vabicaserin

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00541996
First received: October 5, 2007
Last updated: December 3, 2007
Last verified: December 2007
History of Changes
  Purpose

The purpose of this study is to determine the absorption rate of four oral formulations of vabicaserin.


Condition Intervention Phase
Schizophrenia
 Drug: vabicaserin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Assess the bioavailability of four oral formulations of vabicaserin.

Secondary Outcome Measures:
  • Obtain additional safety and tolerability data for vabicaserin in healthy male subjects.

Study Start Date: August 2007
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541996

Locations
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00541996     History of Changes
Other Study ID Numbers: 3153A1-1116
Study First Received: October 5, 2007
Last Updated: December 3, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013