A Four-Way Cross-Over Study To Compare The Plasma Concentrations Of PF-02413873 After Oral Administration Of Several Doses As Suspension And As Tablets.
NCT00857571
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Healthy male and female volunteers.
- Female volunteers have to be of non-childbearing potential
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
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Descriptive Information | ||||
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Brief Title ICMJE | A Four-Way Cross-Over Study To Compare The Plasma Concentrations Of PF-02413873 After Oral Administration Of Several Doses As Suspension And As Tablets. | |||
Official Title ICMJE | An Open-Label Randomized Incomplete Block Four-Way Crossover Study To Evaluate The Dose Response Of PF-02413873 Tablets And PF-02413873 Suspension. | |||
Brief Summary | The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets | |||
Detailed Description | Not 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: Basic Science | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | Terminated | |||
Actual Enrollment ICMJE | 12 | |||
Original Estimated Enrollment ICMJE | 30 | |||
Actual Study Completion Date ICMJE | May 2009 | |||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Singapore | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00857571 | |||
Other Study ID Numbers ICMJE | B0461003 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | December 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |