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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00838058 |
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Date of registration:
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02/02/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.
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Scientific title:
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An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00838058 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- aged 18-55 and healthy
Exclusion Criteria:
- severe chronic or uncontrolled medical or psychiatric conditions, including drug
abuse
- pregnant or wanting to become pregnant
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Rheumatoid Arthritis
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Intervention(s)
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Drug: CE 224,535
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Drug: CE-224,535
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Primary Outcome(s)
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pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2
[Time Frame: 48 hrs]
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Secondary Outcome(s)
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safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing
[Time Frame: 48 hrs]
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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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