Clinical Pharmacology | Amgevita Phase 1 Study | Amgen
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What’s behind amgevita®
MAKES THE DIFFERENCE

PHASE 1 STUDY

Bioequivalent to Humira® in phase 1 clinical pharmacokinetic study

AMGEVITA® was shown to be bioequivalent to Humira® for PK parameters1*
  • Mean serum concentration versus time profiles for AMGEVITA® and Humira® in healthy adults1*
  • Ratio of adjusted least squares geometric means (90% CI)1
AUCinf: Area under the concentration curve versus time from zero to infinity; AUClast: Area under the concentration curve from the time of dosing to the last measurable concentration; CI: Confidence interval; Cmax: Maximum serum concentration; PK: Pharmacokinetic.
*A randomised, single-blind, single-dose, 3-arm, parallel-group study to determine PK equivalence of AMGEVITA® and Humira® in healthy subjects. The primary objective was to evaluate bioequivalence of AMGEVITA® and Humira® in terms of AUCinf and Cmax (equivalence criteria: 90% CI for geometric mean ratio within 0.80–1.25).
1. Kaur P, et al. Ann Rheum Dis. 2017;79;526–33.

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▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.