A Study To Compare The Amount Of CP-690,550 That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Two Different Strength Tablets Of CP-690,550
NCT01277991
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- Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
Subjects with 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 the time of dosing).
Personal or family history of hereditary immunodeficiency (eg, severe - Evidence of any
clinically significant illness, medical condition, or disease.
- Evidence or history of any clinically significant infections within the past 3 months.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5
cigarettes per day.
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Descriptive Information | ||||
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Brief Title ICMJE | A Study To Compare The Amount Of CP-690,550 That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Two Different Strength Tablets Of CP-690,550 | |||
Official Title ICMJE | Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2-period, Crossover, Bioequivalence Study Comparing Phase 2b 1 Mg And 5 Mg Tablet Formulations Of Cp-690,550 Under Fasted Conditions | |||
Brief Summary | In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate occasions using one of two different strength tablets each time. The amount of CP-690,550 available in the blood following administration of each tablet will be measured and compared. The overall aim of the study is to establish that a similar amount of CP-690,550 is absorbed into the blood following administration of the same dose of each different strength tablet . | |||
Detailed Description | This is a bioequivalence study for CP-690,550. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) | |||
Condition ICMJE | Arthritis, Rheumatoid | |||
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 | Completed | |||
Estimated Enrollment ICMJE | 30 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2011 | |||
Actual Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Subjects with 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 the time of dosing). Personal or family history of hereditary immunodeficiency (eg, severe - Evidence of any clinically significant illness, medical condition, or disease.
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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 | NCT01277991 | |||
Other Study ID Numbers ICMJE | A3921135 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | April 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |