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Please Detailed Description for termination reason.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Other | This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults |
|
| Cohort 2 | Other | This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf) | Days 1 through 7 | |
| Metformin and PD 0332334 AUC from 0 to last quantifiable concentration (AUClast) | Days 1 through 7 | |
| Metformin and PD 0332334 half-life (t1/2) | Days 1 through 7 | |
| Metformin and PD 0332334 maximum plasma concentration | Days 1 through 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical safety laboratories | Days 1 through 7 | |
| Incidence, duration and severity of adverse events when study medications administered alone and concurrently | Days 1 through 7 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Singapore | 188770 | Singapore |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| C583768 | imagabalin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin | Drug | Single, oral, 500 mg of metformin immediate release |
|
| PD 0332334 | Drug | 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 |
|
| PD 0332334 | Drug | Single, oral, 300 mg dose of PD 0332334 immediate release formulation |
|
| Discontinuation due to adverse events when study medications administered alone and concurrently |
| Days 1 through 7 |
| 12-lead ECGs | Days 1 through 7 |
| Vital signs | Days 1 through 7 |