Back to resultsStudy Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy Subjects
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
lecozotan SR
Sponsored by
About this trial
This is an interventional health services research trial for Alzheimer Disease
Eligibility Criteria
Inclusion criteria:
- Generally healthy, man and women, aged 18 to 50 years.
Exclusion criteria:
- History or active presence of clinically important medical disease.
Sites / Locations
Outcomes
Primary Outcome Measures
Pharmacokinetic (PK) analyses
Secondary Outcome Measures
Full Information
NCT ID
NCT00494962
First Posted
June 29, 2007
Last Updated
December 3, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00494962
Brief Title
Study Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy Subjects
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
To determine the bioequivalence between two 5-mg tablets of lecozotan and the new 10-mg tablet of lecozotan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
lecozotan SR
Primary Outcome Measure Information:
Title
Pharmacokinetic (PK) analyses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Generally healthy, man and women, aged 18 to 50 years.
Exclusion criteria:
History or active presence of clinically important medical disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Germany, medinfoDEU@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy Subjects
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