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Study Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy Subjects

This study has been completed.

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00494962
  Purpose

To determine the bioequivalence between two 5-mg tablets of lecozotan and the new 10-mg tablet of lecozotan.


Condition Intervention Phase
Alzheimer Disease
Drug: lecozotan SR
Phase I

Genetics Home Reference related topics:   Alzheimer disease   

MedlinePlus related topics:   Alzheimer's Disease   

Drug Information available for:   Lecozotan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Health Services Research, Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study
Official Title:   An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study Between Two 5-mg Tablets and a New 10-mg Tablet Formulation of Lecozotan SR in Healthy Subjects.

Further study details as provided by Wyeth:

Primary Outcome Measures:
  • Pharmacokinetic (PK) analyses

Estimated Enrollment:   40
Study Start Date:   June 2007
Estimated Study Completion Date:   June 2007

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion criteria:

  • Generally healthy, man and women, aged 18 to 50 years.

Exclusion criteria:

  • History or active presence of clinically important medical disease.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494962

Locations
Germany
      Neuss, Germany, 41460

Sponsors and Collaborators
Wyeth

Investigators
Study Director:     Medical Monitor     Wyeth    
Principal Investigator:     Trial Manager     For Germany, medinfoDEU@wyeth.com    
  More Information


Study ID Numbers:   3098B1-1147
First Received:   June 29, 2007
Last Updated:   December 3, 2007
ClinicalTrials.gov Identifier:   NCT00494962
Health Authority:   Germany: Ethics Commission;   Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Healthy
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 06, 2008




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