Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate the plasma drug concentrations of three formulations of PF-05190457 after administration of single doses to healthy volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg PF-05190457 | Experimental | Three fasted treatments and fed with the short-duration osmotic capsule |
|
| 100 mg PF - 05190457 | Experimental | Three fasted treatments and fed with the long-duration osmotic capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05190457 | Drug | 100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state |
|
| Measure | Description | Time Frame |
|---|---|---|
| The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between formulations as data permit. | 0 - 48 hours post dose | |
| The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between formulations as data permit. | 0 - 48 hours post dose | |
| The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Time of Maximum concentration (Tmax) as data permit. | 0 - 48 hours post dose | |
| The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Elimination of half-life (t ½ ) as data permit. | 0 - 48 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between fed states as data permit. | 0 - 48 hours post dose | |
| The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between fed states as data permit. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Singapore | 188770 | Singapore |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000606714 | PF-5190457 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PF-05190457 | Drug | 100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state |
|
| PF-05190457 | Drug | 100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state |
|
| PF-05190457 | Drug | 100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state |
|
| PF-05190457 | Drug | 100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state |
|
| PF-05190457 | Drug | 100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state |
|
| PF-05190457 | Drug | 100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state |
|
| PF-05190457 | Drug | 100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state |
|
| 0 - 48 hours post dose |
| Changes in plasma glucose and insulin due to single doses of three formulations of PF-05190457 will be estimated. | 0 - 24 hours post dose |
| D004700 | Endocrine System Diseases |