Study To Compare Single Dose Of Three Modified Release Formulations Of PF-04937319 With Immediate Release Material-Sparing-Tablet (IR MST) Formulation Previously Studied In Adults With Type 2 Diabetes Mellitus.
NCT ID: NCT02206607
Last Updated: 2016-03-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2014-09-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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PF-04937319 IR MST
Reference formulation
PF-04937319 IR MST
Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch
PF-04937319 MR 1
Test MR #1
PF-04937319 MR 1
Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
PF-04937319 MR 2
Test MR #2
PF-04937319 MR 2
Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
PF-04937319 MR 3
Test MR #3
PF-04937319 MR 3
Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
Interventions
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PF-04937319 IR MST
Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch
PF-04937319 MR 1
Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
PF-04937319 MR 2
Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
PF-04937319 MR 3
Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with diabetic complications
* Female subjects who are pregnant or planning to become pregnant
* Subjects with unstable medical conditions (eg, hypertension)
18 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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High Point Clinical Trials Center
High Point, North Carolina, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
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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B1621015
Identifier Type: -
Identifier Source: org_study_id
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