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The study will determine if bioequivalence can be claimed between the proposed commericializable formulation and the current clinical formulation. Specifically, if the 90% confidence intervals of the ratio for Area under the curve (AUC) and maximum concentration (CMax) are within the 80%-125% guidance limits.
A bioequivalence (BE) study between two formulations of PF-00299804.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Subjects will receive clinical formulation (treatment A) followed by commercializable formulation (treatment B). |
|
| Sequence 2 | Experimental | Subjects will receive commercializable formulation (treatment B) followed by clinical formulation (treatment A). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A-B | Drug | Subjects to receive 3 X 15 mg tablets of the clinical formulation in first period then 1 x 45 mg tablet of the commericializable formulation in 2nd period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma AUCinf of of PF 00299804 | 6-8 weeks | |
| AUClast of PF 00299804 | 6-8 weeks | |
| Cmax of PF 00299804 | 6-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma AUCinf of PF 00299804. | 6-8 weeks | |
| CL/F of PF 00299804. | 6-8 weeks | |
| Tmax of PF 00299804. |
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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 | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Treatment B-A | Drug | Subjects to receive 1 x 45 mg tablet of the commericializable formulation in first period then 3X 15 mg tablets of the clinical formulation in 2nd period. |
|
| 6-8 weeks |
| tlast of PF 00299804. | 6-8 weeks |
| t1/2 of PF 00299804. | 6-8 weeks |
| Plasma AUCinf of PF-05199265 | 6-8 weeks |
| AUClast of PF-05199265 | 6-8 weeks |
| Cmax of PF-05199265 | 6-8 weeks |
| Tmax of PF-05199265 | 6-8 weeks |
| tlast of PF-05199265 | 6-8 weeks |
| Safety laboratory tests, physical examination, concomitant medication and adverse event monitoring | 6-8 weeks |