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This study investigates the safety, tolerability and pharmacokinetics of PF-04191834 when respectively given orally as a single dispersion dose and a single dose of a suspension. The suspension is the test formulation and the dispersion is the formulation with which the novel preparation will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral single dose dispersion 100mg | Active Comparator | Subjects receive a single dose of PF-04191834 as a dispersion |
|
| oral wet milled suspension 100mg | Active Comparator | Subjects receive a single dose of PF-04191834 as a suspension |
|
| oral wet milled suspension 300mg | Active Comparator | Subjects receive a single dose of PF-04191834 as a suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04191834 | Drug | single dose, 100mg, dispersion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum concentration(Tmax) of PF-04191834 in plasma. | 3 days | |
| Area under the curve (AUClast) from the time of dosing to the last data point taken for PF-04191834. | 3 days | |
| Area under the curve from the time of dosing extrapolated to infinity(AUCinf) of PF-04191834. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) for PF-04191834 in plasma. | 3 days | |
| Elimination half-life (t1/2) of PF-04191834 | 3 days | |
| Sheehan suicidality tracking scale (SSTS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PF-04191834 |
| Drug |
single dose, 100mg, suspension |
|
| PF-04191834 | Drug | single dose, 300mg, suspension |
|
| Screening and last Day of Period 3 |
| Number of adverse events in patients as a measure of safety and tolerability. | Throughout the study. |