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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.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00494962
First received: June 29, 2007
Last updated: December 3, 2007
Last verified: December 2007
History of Changes
  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 1

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

Resource links provided by NLM:

U.S. FDA Resources

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

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 is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, medinfoDEU@wyeth.com
  More Information

No publications provided

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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013