Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00494962 |
Date of registration:
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29/06/2007 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy Subjects
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Scientific title:
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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. |
Date of first enrolment:
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June 2007 |
Target sample size:
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40 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00494962 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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Phase:
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Phase 1
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Countries of recruitment
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Germany
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Contacts
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Name:
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Medical Monitor |
Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
Address:
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Telephone:
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Email:
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Affiliation:
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For Germany, medinfoDEU@wyeth.com |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Generally healthy, man and women, aged 18 to 50 years.
Exclusion criteria:
- History or active presence of clinically important medical disease.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer Disease
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Intervention(s)
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Drug: lecozotan SR
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Primary Outcome(s)
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Pharmacokinetic (PK) analyses
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Secondary ID(s)
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3098B1-1147
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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