Clinical trial NCT03273088 - References

Bioequivalence — Pharmacokinetic, Safety and Tolerability Study of Altebrel in Healthy Male Subjects

Citation(s)

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  The comparability of etanercept pharmacokinetics in healthy Japanese and American subjects. J Clin Pharmacol. 2006 Apr;46(4):418-23.
•   Lee YJ, Shin D, Kim Y, Kang J, Gauliard A, Fuhr R
  A randomized phase l pharmacokinetic study comparing SB4 and etanercept reference product (Enbrel®) in healthy subjects. Br J Clin Pharmacol. 2016 Jul;82(1):64-73. doi: 10.1111/bcp.12929. Epub 2016 May 2.
•   Yi S, Kim SE, Park MK, Yoon SH, Cho JY, Lim KS, Shin SG, Jang IJ, Yu KS
  Comparative pharmacokinetics of HD203, a biosimilar of etanercept, with marketed etanercept (Enbrel®): a double-blind, single-dose, crossover study in healthy volunteers. BioDrugs. 2012 Jun 1;26(3):177-84. doi: 10.2165/11631860-000000000-00000.

A Randomised, Two-period, Two-sequence, Single-dose and Cross-over Study in Healthy Subjects to Demonstrate Pharmacokinetic Equivalence of Altebrel (Produced by Aryogen Pharmed) and Enbrel® (the Reference Drug, Produced by Amgen Company)

Details for clinical trial NCT03273088