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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002315-15 | EudraCT Number |
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This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way. In part 2 of the study, depending on the results of part 1, either none, one or 2 of the formulations tested in part 1 will be tested comparing the same formulation when given either with or without food. Additionally, depending on the results of part 1 of the study, different doses of the formulations may be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 soft gel capsules of 20 mg tafamidis meglumine | Experimental |
| |
| 48.8 mg tafamidis soft gel capsule formulation 1 | Experimental |
| |
| 48.8 mg tafamidis soft get capsule formulation 2 | Experimental |
| |
| 61 mg tafamidis soft gel capsule formulation 1 | Experimental |
| |
| 61 mg tafamidis soft gel capsule formulation 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tafamidis | Drug | relative bioavailability |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time Curve (AUC) | 120 hours | |
| Maximum Observed Plasma Concentration (Cmax) | 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 120 hours | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 120 hours | |
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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 Clinical Research Unit | Brussels | B-1070 | Belgium |
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| ID | Term |
|---|---|
| C547076 | tafamidis |
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| tafamidis | Drug | fasted |
|
| tafamidis | Drug | fed |
|
| Plasma Decay Half-Life (t1/2) |
| 120 hours |
| Area Under the Curve from Time zero to infinity | 120 hours |