Pharmacokinetic, Safety and Tolerability Study of Altebrel in Healthy Male Subjects
Status:
Completed
Trial end date:
2017-03-15
Target enrollment:
Participant gender:
Summary
This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate
Altebrel relative to etanercept reference product (Enbrel®) and evaluate safety and
tolerability of Altebrel, in a crossover fashion in healthy male volunteers after
administration of a single dose (25 mg) of etanercept.
The primary objective of this study is to demonstrate that the PK of Altebrel is similar to
its originator, Enbrel®, as assessed by the area under the serum concentration time curve
(AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax.
The secondary objectives of the study are:
To further compare the PK of Altebrel and Enbrel®. To assess the safety of Altebrel.