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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.

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
High Point Clinical Trials Center
High Point, North Carolina, 27265 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adults with type 2 diabetes, on stable background metformin therapy either alone or in
combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones
(TZDs)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients with cardiovascular event within 6 months of screening

- Patients with diabetic complications

- Female subjects who are pregnant or planning to become pregnant

- Subjects with unstable medical conditions (eg, hypertension)

NCT02206607
Pfizer
Completed
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.

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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.
A Phase 1, Randomized, Open-label, Cross-over, Single-day Study Of Pf-04937319 To Characterize Relative Bioavailability, Tolerability, And Pharmacodynamics Of Four Oral Formulations In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three modified release formulations of PF-04937319 compared with the immediate release material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Drug: PF-04937319 IR MST
    Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch
  • Drug: 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
  • Drug: 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
  • Drug: 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
  • Experimental: PF-04937319 IR MST
    Reference formulation
    Intervention: Drug: PF-04937319 IR MST
  • Experimental: PF-04937319 MR 1
    Test MR #1
    Intervention: Drug: PF-04937319 MR 1
  • Experimental: PF-04937319 MR 2
    Test MR #2
    Intervention: Drug: PF-04937319 MR 2
  • Experimental: PF-04937319 MR 3
    Test MR #3
    Intervention: Drug: PF-04937319 MR 3
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
January 2015
January 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults with type 2 diabetes, on stable background metformin therapy either alone or in combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones (TZDs)

Exclusion Criteria:

  • Patients with cardiovascular event within 6 months of screening
  • Patients with diabetic complications
  • Female subjects who are pregnant or planning to become pregnant
  • Subjects with unstable medical conditions (eg, hypertension)
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02206607
B1621015
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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