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A randomized, open-label, two-way crossover study to assess the tolerability and pharmacokinetics of Tacrobell® Tab. and Prograf® Cap. after a single oral dose in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrobell tab. 2mg | Experimental | 2mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover) |
|
| Prograf cap. 2mg | Active Comparator | 1mg/capsule, PO, 2 capsule once daily for Period I & II D1(crossover) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrobell tab. 2mg | Drug |
| ||
| Prograf cap. 2mg |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | up to 96 hous postdose | |
| Cmax | up to 96 hous postdose |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | up to 96 hous postdose | |
| Tmax | up to 96 hous postdose | |
| t1/2 |
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Inclusion Criteria:
Exclusion Criteria:
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|
| up to 96 hous postdose |
| CL/F | up to 96 hous postdose |