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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000706-19 | EudraCT Number |
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Each subject will be given tafamidis after either a high fat meal or while fasted. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one week. After about 14 days, subjects will take either a different dose of tafamidis or the same dose under the opposite meal condition. Tafamidis concentrations from the three different conditions will be compared to determine if they are approximately the same.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 tablets of 12.2 mg tafamdis free acid | Experimental |
| |
| 4 tablets of 12.2 mg tafamidis free acid | Experimental |
| |
| 5 tablets of 12.2 mg tafamidis free acid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tafamidis | Drug | fasted |
| |
| tafamidis |
| 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 (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: - Healthy males or females of non-child bearing potential. - Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).
Exclusion Criteria: - Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic). - Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
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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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| Drug |
high fat meal |
|
| tafamidis | Drug |
|
|
| 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 |