1. To estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body 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.
Detailed Description: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
24
225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release
Single, oral, 500 mg of metformin immediate release
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
Pfizer Investigational Site
Singapore, Singapore
Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf)
Time frame: Days 1 through 7
Metformin and PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
Time frame: Days 1 through 7
Metformin and PD 0332334 half-life (t1/2)
Time frame: Days 1 through 7
Metformin and PD 0332334 maximum plasma concentration
Time frame: Days 1 through 7
Clinical safety laboratories
Time frame: Days 1 through 7
Incidence, duration and severity of adverse events when study medications administered alone and concurrently
Time frame: Days 1 through 7
Discontinuation due to adverse events when study medications administered alone and concurrently
Time frame: Days 1 through 7
12-lead ECGs
Time frame: Days 1 through 7
Vital signs
Time frame: Days 1 through 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Single, oral, 300 mg dose of PD 0332334 immediate release formulation