Bioequivalence of 1 and 5 mg tacrolimus capsules using a replicate study design.

@article{Bekersky1999BioequivalenceO1,
  title={Bioequivalence of 1 and 5 mg tacrolimus capsules using a replicate study design.},
  author={Ihor Bekersky and Dan Dressler and Wayne A. Colburn and Qais A Mekki},
  journal={Journal of clinical pharmacology},
  year={1999},
  volume={39 10},
  pages={1032-7}
}
Tacrolimus (FK506, Prograf) is marketed for the prophylaxis of organ rejection following allogenic liver or kidney transplantation. A previously conducted, randomized, 24-subject, crossover bioavailability study of 1 and 5 mg capsules (one period each) failed to demonstrate bioequivalence. A single-dose, four-period, four-sequence, randomized, crossover, replicate study (N = 32) was therefore used to evaluate the bioequivalence of the marketed 1 and 5 mg capsules in healthy volunteers… CONTINUE READING