Bioequivalence of tacrolimus formulations with different dynamic solubility and in-vitro dissolution profiles.

This study was to evaluate the pharmacokinetics and bioequivalence of two tacrolimus formulations which had different in vitro drug release profiles. Dynamic solubility, in vitro dissolution profiles of the two formulations, and their influence on pharmacokinetics were examined. The male volunteers were randomly assigned to receive a single 1-mg capsule of the test or reference formulation and pharmacokinetic parameters were determined using a noncompartmental method.