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All subjects in this study will be given tafamidis. After swallowing a single pill of tafamidis, measurements including blood samples will be compared to see if tafamidis made in different ways is about the same. After approximately 28 days subjects will be given another pill of tafamidis and the study measurements will be repeated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tafamidis | Experimental |
| |
| Tafamudus Free Acid | Experimental |
| |
| 20 mg new soft gelatin capsule | Experimental |
| |
| 4 capsules of 20 mg tafamidis of commercial formulation | Experimental |
| |
| 4 capsules of 12.2 mg tafamidis of free acid tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafamidis | Drug | 20 mg of current commercial formulation. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). | 168 hours |
| Maximum Observed Plasma Concentration (Cmax) | 168 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 168 hours |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |
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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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| ID | Term |
|---|---|
| C547076 | tafamidis |
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| Tafamidis |
| Drug |
12.2 mgA free acid tablet. |
|
| Tafamidis | Drug | 20 mg new soft gelatin capsule. |
|
| Tafamidis | Drug | 4 capsules of 20 mg tafamidis of current commercial formulation. |
|
| Tafamidis | Drug | 4 capsules of 12.2 mg tafamidis of free acid tablet.. |
|
| 6 |