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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002769-23 | EudraCT Number |
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2 different formulations of tafamidis will be compared under both fed and fasted conditions. Subjects will be fasted overnight or fed. After swallowing one of the tafamidis formulations, tafamidis blood concentrations will be measured periodically for 8 days. After 16 days, subjects will take a different formulation in the fed or fasted state or take the same formulation in the opposite feeding condition. This will be repeated, 16 days apart, until all subjects have taken each formulation both fed and fasted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 61 mgA tafamidis free acid soft gelatin capsule fed | Experimental | fasted |
|
| 61 mgA tafamidis free acid soft gelatin capsule fasted | Experimental | fed |
|
| 4 × 20 mg tafamidis meglumine soft gelatin capsules fed | Experimental | fed |
|
| 4 × 20 mg tafamidis meglumine soft gelatin capsules fasted | Experimental | fasted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tafamidis | Drug | bioavailability study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve 0-72 hours (AUC72) | 72 hrs | |
| maximum observed plasma concentration (Cmax) | 168 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 168 hrs | |
| Mean residence time (MRT) | 168 hrs | |
| 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 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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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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| ID | Term |
|---|---|
| C547076 | tafamidis |
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| 168 hrs |
| Plasma Decay Half-Life (t1/2) | 168 hrs |
| Area under the curve from zero to infinity (AUCinf) | 168 hrs |