Immunosuppression Clinical Trial
Official title:
An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Tacrobell Capsule 1mg Versus Prograf Capsule 1mg in Healthy Subjects
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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