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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014