RESEARCH - Bioequivalence of liquid and reconstituted lyophilized Enbrel subcutaneous injections

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J Clin Pharmacol. 2006 Jun;46(6):654-61.

Bioequivalence of liquid and reconstituted lyophilized etanercept

subcutaneous injections.

Sullivan JT, Ni L, Sheelo C, Salfi M, Peloso PM.

Amgen Inc, One Amgen Center Drive, Mailstop 38-4-C, Thousand Oaks, CA 91320,

USA. jtsulliv@...

The objective of this study was to compare the pharmacokinetics of liquid

and reconstituted lyophilized etanercept. This single-center, open-label

study had a 2-period crossover design in which 36 healthy subjects were

randomly assigned in a 1:1 ratio to etanercept (liquid/lyo or lyo/liquid).

The treatments were separated by 28 days. Blood samples were obtained

predose and at 10 predetermined time points postdose. Serum concentrations

were determined by enzyme-linked immunosorbent assay. Noncompartmental

pharmacokinetic parameters were analyzed using a standard crossover analysis

of variance model. Thirty-three subjects completed both treatment periods.

Geometric mean values (adjusted) of area under the serum drug

concentration-time curve from time zero to the time of the final

quantifiable sample, area under the serum drug concentration-time curve from

time zero to infinity, and maximum concentration obtained with the 50-mg/mL

liquid etanercept injection were 93.0%, 90.7%, and 98.5% of the respective

parameters for 2 injections of 25 mg/mL reconstituted formulation. All

associated confidence intervals were within the predefined equivalence

interval of 80% to 125%. No differences in safety profiles of the 2

formulations were apparent. Liquid etanercept was bioequivalent to the

reconstituted lyophilized etanercept formulation.

PMID: 16707412

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Retrieve & dopt=Abstra\

ct & list_uids=16707412

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