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To evaluate the effect of food on the pharmacokinetics of apixaban administered as commercial image tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Period I: fasting state, Period II: fed state |
|
| 2 | Experimental | Period I: fed state, Period II: fasting state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Period I: 1 x 5 mg Commercial Image Tablet in fasting state(single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: 1 x 5 mg Commercial Image Tablet in fed state (single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | dosing to 3 days | |
| AUC(INF) | dosing to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(tlqc) | dosing to 3 days | |
| Tmax | dosing to 3 days | |
| t1/2 |
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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 | Singapore | 188770 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27292282 | Derived | Song Y, Chang M, Suzuki A, Frost RJ, Kelly A, LaCreta F, Frost C. Evaluation of Crushed Tablet for Oral Administration and the Effect of Food on Apixaban Pharmacokinetics in Healthy Adults. Clin Ther. 2016 Jul;38(7):1674-1685.e1. doi: 10.1016/j.clinthera.2016.05.004. Epub 2016 Jun 10. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C522181 | apixaban |
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|
| Apixaban | Drug | Period I: 1 x 5 mg Commercial Image Tablet in fed state(single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: 1 x 5 mg Commercial Image Tablet in fasting state (single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period) |
|
| dosing to 3 days |