| Trial ID: | L6199 |
| Source ID: | NCT01522807
|
| Associated Drug: |
Pf-05190457
|
| Title: |
A Study Of Three PF-05190457 Formulations In Healthy Volunteers
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: PF-05190457|DRUG: PF-05190457|DRUG: PF-05190457|DRUG: PF-05190457|DRUG: PF-05190457|DRUG: PF-05190457|DRUG: PF-05190457|DRUG: PF-05190457
|
| Outcome Measures: |
Primary: 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 | Secondary: 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., 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
|
| Sponsor/Collaborators: |
Sponsor: Pfizer
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2011-09
|
| Completion Date: |
2011-11
|
| Results First Posted: |
|
| Last Update Posted: |
2012-02-01
|
| Locations: |
Pfizer Investigational Site, Singapore, 188770, Singapore
|
| URL: |
https://clinicaltrials.gov/show/NCT01522807
|