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The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and prograf capsule 1mg.
This will be an open label, randomized, single dose, 2-treatment, 2-period crossover study in healthy volunteers.Study treatments will be administered under fasting conditions.
Blood samples for the analysis of tacrolimus in blood will be obtained as follows: Predose(immediately prior to dosing), and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrobell capsule 1mg | Experimental | Tacrolimus 1mg / 1 capsule |
|
| Prograf capsule 1mg | Active Comparator | Tacrolimus 1mg / 1 capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrobell capsule 1mg | Drug | 1 capsule, oral, over the period I&II(crossover) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | AUClast: Area under the blood concentration-time profile from time zero to the time of the last quantifiable concentration | At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdese |
| Cmax | Cmax: Maximum blood concentration | At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdese |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | ACUinf: Area under the blood concentration-time profile from time zero extrapolated to infinite time | At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose |
| Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyeong Ki Lee, MD, Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Prograf capsule 1mg |
| Drug |
1 capsule, oral, over the period I&II(crossover) |
|
Tmax: Time for Cmax
| At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose |
| T1/2 | T1/2: Terminal elimination half-life | At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose |
| CL/F | CL/F: Apparent Clearance | At pre-dose (immediately prior to dosing) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose |