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

Last updated on November 19, 2019

FOR MORE INFORMATION
Study Location
Neuss, , 41460 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- History or active presence of clinically important medical disease.

NCT00494962
Pfizer
Completed
Study Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy Subjects

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Descriptive Information
Brief Title  ICMJE Study Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy Subjects
Official Title  ICMJE 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.
Brief SummaryTo determine the bioequivalence between two 5-mg tablets of lecozotan and the new 10-mg tablet of lecozotan.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE Drug: lecozotan SR
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 29, 2007)
40
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion criteria:

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

Exclusion criteria:

  • History or active presence of clinically important medical disease.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00494962
Other Study ID Numbers  ICMJE 3098B1-1147
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Germany, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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