Bioequivalence Study of Tacrolimus in Healthy Volunteers
Status:
Completed
Trial end date:
2021-06-17
Target enrollment:
Participant gender:
Summary
This is an in-vivo study to investigate the bioequivalence of generic tacrolimus and its
reference listed drug (RLD). The objective of this study is to investigate the bioequivalence
of generic Tacrolimus and RLD in healthy male and non-pregnant, non-lactating female
volunteers under fasting conditions. The outcome of this study will help further
understanding about pharmacokinetic (PK) performance of tacrolimus in a healthy volunteer
population and improve review standards for bioequivalence of narrow therapeutic index (NTI)
drugs.