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- Healthy Chinese Volunteers
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- Clinically significant infections within the past 3 months
- Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or
human immunodeficiency virus
- Pregnant or nursing women
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Descriptive Information | ||||
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Brief Title ICMJE | CP-690,550 Pharmacokinetics In Healthy Chinese Subjects | |||
Official Title ICMJE | An Open Label, Single And Multiple Dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Healthy Chinese Subjects | |||
Brief Summary | This study is designed to evaluate the levels of CP-690,550 in the blood of healthy Chinese subjects following both single doses and multiple doses of drug. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE | Drug: CP-690,550
Days 1 and 6 dose of 10 mg once daily Days 2-5 doses of 10 mg twice daily | |||
Study Arms ICMJE | Experimental: CP-690,550 Dose Group
Intervention: Drug: CP-690,550 | |||
Publications * | Krishnaswami S, Wang T, Yuan Y, Alvey CW, Checchio T, Peterson M, Shi H, Riese R. Single- and multiple-dose pharmacokinetics of tofacitinib in healthy Chinese volunteers. Clin Pharmacol Drug Dev. 2015 Sep;4(5):395-9. doi: 10.1002/cpdd.202. Epub 2015 Jul 16. | |||
* 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 | 12 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | October 2010 | |||
Actual Primary Completion Date | October 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01101919 | |||
Other Study ID Numbers ICMJE | A3921065 | |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | November 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |