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The purpose of this study is the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 mg soft gelatin capsule | Experimental |
| |
| 40 mg (20 mg*2) soft gelatin capsule | Experimental |
| |
| Placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafamidis meglumin | Drug | A single oral dose of 20 mg capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of tafamidis over time (AUClast). | 2 months | |
| Plasma concentration of tafamidis over time (Cmax). | 2 months | |
| Plasma concentration of tafamidis over time (Tmax). | 2 months | |
| If data permit, AUCinf and t1/2 will be determined. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| The percent stabilization of TTR tetramer will be defined at Cmax in each subject and compared between Japanese volunteers and Western volunteers. | 2 months |
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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 | Glendale | California | 91206 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Tafamidis meglumin | Drug | A single oral dose of 40 mg capsule. |
|
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| Placebo | Drug | A single oral dose of matched placebo. |
|