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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003271-35 | EudraCT Number |
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Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis blood concentrations will be measured periodically for one week. After about 20 days, subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis concentrations from the two different formulations will be compared to determine if they are approximately the same.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Tafamidis | Experimental |
| |
| 2. Tafamidis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafamidis | Drug | 20 mg of current commercial formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Concentration-Time Curve (AUC) | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. | 168 hours |
| Maximum Observed Plasma Concentration (Cmax) | 168 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) | 168 hours |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
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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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| 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 | 20 mg of new formulation |
|
|
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) | 168 hours |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 168 hours |