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

NCT ID: NCT01277991

Last Updated: 2011-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-03-31

Brief Summary

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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

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This is a bioequivalence study for CP-690,550.

Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Sequence 1

Group Type EXPERIMENTAL

Treatment A

Intervention Type DRUG

Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)

Treatment B

Intervention Type DRUG

Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)

Sequence 2

Group Type EXPERIMENTAL

Treatment B

Intervention Type DRUG

Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)

Treatment A

Intervention Type DRUG

Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)

Interventions

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Treatment A

Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)

Intervention Type DRUG

Treatment B

Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)

Intervention Type DRUG

Treatment B

Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)

Intervention Type DRUG

Treatment A

Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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).

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.

* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Singapore, , Singapore

Site Status

Countries

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Singapore

Related Links

Other Identifiers

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A3921135

Identifier Type: -

Identifier Source: org_study_id

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