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Randomized, Open‐Label, Single‐Dose, Parallel‐Group Pharmacokinetic Study of PF‐06410293 (adalimumab‐afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects
This open‐label, single‐dose, randomized, parallel‐group, 2‐arm phase 1 bioequivalence (BE) study assessed the pharmacokinetics (PK), safety, and tolerability of PF‐06410293 (ADL‐PF), an adalimumab (ADL) biosimilar, following administration by prefilled pen (PFP) or prefilled syringe (PFS). A total...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518774/ https://www.ncbi.nlm.nih.gov/pubmed/33765358 http://dx.doi.org/10.1002/cpdd.939 |
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author | Cox, Donna S. Alvarez, Daniel F. Bock, Amy E. Cronenberger, Carol L. |
author_facet | Cox, Donna S. Alvarez, Daniel F. Bock, Amy E. Cronenberger, Carol L. |
author_sort | Cox, Donna S. |
collection | PubMed |
description | This open‐label, single‐dose, randomized, parallel‐group, 2‐arm phase 1 bioequivalence (BE) study assessed the pharmacokinetics (PK), safety, and tolerability of PF‐06410293 (ADL‐PF), an adalimumab (ADL) biosimilar, following administration by prefilled pen (PFP) or prefilled syringe (PFS). A total of 164 healthy adult subjects were randomized (1:1) to receive ADL‐PF (40 mg subcutaneously) in the lower abdomen or upper anterior thigh by PFS or PFP; 163 subjects were included in the primary PK analysis. The concentration‐time profiles of the ADL‐PF PFS and PFP treatment arms were similar. The 90% confidence intervals for the test/reference ratios of the primary end points (area under the serum concentration‐time profile from time 0 to 2 weeks after dosing and maximum observed serum concentration) fell within the 80.00%‐125.00% prespecified margin for BE. Comparable numbers of subjects experienced adverse events (AEs) between treatment groups, and injection‐site pain was similar at all times and for the 2 injection‐site locations. This study demonstrated the BE of ADL‐PF following subcutaneous administration using either a PFS or PFP device. ADL‐PF by PFS or PFP injection was well tolerated, with the distribution of AEs, including injection‐site reactions, being similar between treatment arms. |
format | Online Article Text |
id | pubmed-8518774 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-85187742021-10-21 Randomized, Open‐Label, Single‐Dose, Parallel‐Group Pharmacokinetic Study of PF‐06410293 (adalimumab‐afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects Cox, Donna S. Alvarez, Daniel F. Bock, Amy E. Cronenberger, Carol L. Clin Pharmacol Drug Dev Articles This open‐label, single‐dose, randomized, parallel‐group, 2‐arm phase 1 bioequivalence (BE) study assessed the pharmacokinetics (PK), safety, and tolerability of PF‐06410293 (ADL‐PF), an adalimumab (ADL) biosimilar, following administration by prefilled pen (PFP) or prefilled syringe (PFS). A total of 164 healthy adult subjects were randomized (1:1) to receive ADL‐PF (40 mg subcutaneously) in the lower abdomen or upper anterior thigh by PFS or PFP; 163 subjects were included in the primary PK analysis. The concentration‐time profiles of the ADL‐PF PFS and PFP treatment arms were similar. The 90% confidence intervals for the test/reference ratios of the primary end points (area under the serum concentration‐time profile from time 0 to 2 weeks after dosing and maximum observed serum concentration) fell within the 80.00%‐125.00% prespecified margin for BE. Comparable numbers of subjects experienced adverse events (AEs) between treatment groups, and injection‐site pain was similar at all times and for the 2 injection‐site locations. This study demonstrated the BE of ADL‐PF following subcutaneous administration using either a PFS or PFP device. ADL‐PF by PFS or PFP injection was well tolerated, with the distribution of AEs, including injection‐site reactions, being similar between treatment arms. John Wiley and Sons Inc. 2021-03-25 2021-10 /pmc/articles/PMC8518774/ /pubmed/33765358 http://dx.doi.org/10.1002/cpdd.939 Text en © 2021 Pfizer Inc. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Articles Cox, Donna S. Alvarez, Daniel F. Bock, Amy E. Cronenberger, Carol L. Randomized, Open‐Label, Single‐Dose, Parallel‐Group Pharmacokinetic Study of PF‐06410293 (adalimumab‐afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects |
title | Randomized, Open‐Label, Single‐Dose, Parallel‐Group Pharmacokinetic Study of PF‐06410293 (adalimumab‐afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects |
title_full | Randomized, Open‐Label, Single‐Dose, Parallel‐Group Pharmacokinetic Study of PF‐06410293 (adalimumab‐afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects |
title_fullStr | Randomized, Open‐Label, Single‐Dose, Parallel‐Group Pharmacokinetic Study of PF‐06410293 (adalimumab‐afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects |
title_full_unstemmed | Randomized, Open‐Label, Single‐Dose, Parallel‐Group Pharmacokinetic Study of PF‐06410293 (adalimumab‐afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects |
title_short | Randomized, Open‐Label, Single‐Dose, Parallel‐Group Pharmacokinetic Study of PF‐06410293 (adalimumab‐afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects |
title_sort | randomized, open‐label, single‐dose, parallel‐group pharmacokinetic study of pf‐06410293 (adalimumab‐afzb), an adalimumab biosimilar, by subcutaneous dosing using a prefilled syringe or a prefilled pen in healthy subjects |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518774/ https://www.ncbi.nlm.nih.gov/pubmed/33765358 http://dx.doi.org/10.1002/cpdd.939 |
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