Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time
NCT ID: NCT00809536
Last Updated: 2010-02-17
Study Results
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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TERMINATED
PHASE1
24 participants
INTERVENTIONAL
2009-01-31
2009-02-28
Brief Summary
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2. To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body
3. To evaluate the safety and tolerability when PD 0332334 and metformin are administered at the same time.
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Detailed Description
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Additional Study Purpose Details: To assess the pharmacokinetics of metformin and PD 0332334 with concurrent administration.
On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Cohort 1
This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
Metformin
225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release
Metformin
Single, oral, 500 mg of metformin immediate release
Cohort 2
This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
PD 0332334
500 mg q12, oral metformin immediate release administered on Days 1 through Day 6 Single, oral, 300 mg dose of PD 0332334 immediate release formulation administered on Day 3
PD 0332334
Single, oral, 300 mg dose of PD 0332334 immediate release formulation
Interventions
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Metformin
225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release
Metformin
Single, oral, 500 mg of metformin immediate release
PD 0332334
500 mg q12, oral metformin immediate release administered on Days 1 through Day 6 Single, oral, 300 mg dose of PD 0332334 immediate release formulation administered on Day 3
PD 0332334
Single, oral, 300 mg dose of PD 0332334 immediate release formulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female adults
Exclusion Criteria
* Smokers
* Illicit drug use
21 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
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
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A5361031
Identifier Type: -
Identifier Source: org_study_id
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