A randomized, double‐blind, comparative study of the pharmacodynamics and pharmacokinetics of GP40141 (romiplostim biosimilar) and reference romiplostim in healthy male volunteers
Abstract Aims The pharmacodynamic (PD) similarity between GP40141, a proposed romiplostim biosimilar, and reference romiplostim was evaluated. Pharmacokinetics and safety were also assessed. Methods In this phase 1, randomized, double‐blind, single‐dose, crossover comparative study with an adaptive...
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Wiley
2023-10-01
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| Series: | Pharmacology Research & Perspectives |
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| Online Access: | https://doi.org/10.1002/prp2.1125 |
| _version_ | 1797658940333359104 |
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| author | Igor Makarenko Artem Dorotenko Sergey Noskov Veniamin Banko Valeria Saparova Alexandr Khokhlov Evgeniia Zoreeva Andrey Nedorubov Bella Zinnatulina Maria Gefen Roman Drai |
| author_facet | Igor Makarenko Artem Dorotenko Sergey Noskov Veniamin Banko Valeria Saparova Alexandr Khokhlov Evgeniia Zoreeva Andrey Nedorubov Bella Zinnatulina Maria Gefen Roman Drai |
| author_sort | Igor Makarenko |
| collection | DOAJ |
| description | Abstract Aims The pharmacodynamic (PD) similarity between GP40141, a proposed romiplostim biosimilar, and reference romiplostim was evaluated. Pharmacokinetics and safety were also assessed. Methods In this phase 1, randomized, double‐blind, single‐dose, crossover comparative study with an adaptive design, 56 healthy male volunteers were randomized 1:1 to receive a 3 ug × kg−1 subcutaneous dose of GP40141 and reference romiplostim. The PD similarity between GP40141 and the reference romiplostim was determined using the standard equivalence criteria (80%–125%) for the area under the platelet count‐time curve from time 0 to the time of the last sampling for PD (AUCplt) and the maximum observed platelet count (Pmax). Results GP40141 and the reference romiplostim exhibited similar PD profiles. 90% CI for the geometric mean ratios for the primary PD parameters (AUCplt, Pmax) for GP40141 (T) and the reference romiplostim (R) were fully contained within the predefined equivalence limits of 80%–125%: 98.13%–102.42% for AUCplt and 97.56%–105.80% for Pmax. The pharmacokinetic profiles of GP40141 and the reference romiplostim were well described. No adverse events were observed during the clinical trial after the administration of GP40141 and the reference romiplostim. Conclusion This study demonstrates the PD similarity of GP40141 to the reference romiplostim. Both treatments had comparable safety profiles (NCT05652595) |
| first_indexed | 2024-03-11T18:06:41Z |
| format | Article |
| id | doaj.art-e6fff10272504c27af32e229a159a688 |
| institution | Directory Open Access Journal |
| issn | 2052-1707 |
| language | English |
| last_indexed | 2024-03-11T18:06:41Z |
| publishDate | 2023-10-01 |
| publisher | Wiley |
| record_format | Article |
| series | Pharmacology Research & Perspectives |
| spelling | doaj.art-e6fff10272504c27af32e229a159a6882023-10-17T07:30:29ZengWileyPharmacology Research & Perspectives2052-17072023-10-01115n/an/a10.1002/prp2.1125A randomized, double‐blind, comparative study of the pharmacodynamics and pharmacokinetics of GP40141 (romiplostim biosimilar) and reference romiplostim in healthy male volunteersIgor Makarenko0Artem Dorotenko1Sergey Noskov2Veniamin Banko3Valeria Saparova4Alexandr Khokhlov5Evgeniia Zoreeva6Andrey Nedorubov7Bella Zinnatulina8Maria Gefen9Roman Drai10R&D Center, GEROPHARM Saint Petersburg RussiaR&D Center, GEROPHARM Saint Petersburg RussiaClinical Hospital №3 Yaroslavl RussiaR&D Center, GEROPHARM Saint Petersburg RussiaR&D Center, GEROPHARM Saint Petersburg RussiaFederal State Budgetary Educational Institution of Higher Education "Yaroslavl State Medical University" of the Ministry of Health of the Russian Federation Yaroslavl RussiaR&D Center, GEROPHARM Saint Petersburg RussiaInstitute for Translational Medicine and Biotechnology I.M. Sechenov First Moscow State Medical University Moscow RussiaR&D Center, GEROPHARM Saint Petersburg RussiaR&D Center, GEROPHARM Saint Petersburg RussiaR&D Center, GEROPHARM Saint Petersburg RussiaAbstract Aims The pharmacodynamic (PD) similarity between GP40141, a proposed romiplostim biosimilar, and reference romiplostim was evaluated. Pharmacokinetics and safety were also assessed. Methods In this phase 1, randomized, double‐blind, single‐dose, crossover comparative study with an adaptive design, 56 healthy male volunteers were randomized 1:1 to receive a 3 ug × kg−1 subcutaneous dose of GP40141 and reference romiplostim. The PD similarity between GP40141 and the reference romiplostim was determined using the standard equivalence criteria (80%–125%) for the area under the platelet count‐time curve from time 0 to the time of the last sampling for PD (AUCplt) and the maximum observed platelet count (Pmax). Results GP40141 and the reference romiplostim exhibited similar PD profiles. 90% CI for the geometric mean ratios for the primary PD parameters (AUCplt, Pmax) for GP40141 (T) and the reference romiplostim (R) were fully contained within the predefined equivalence limits of 80%–125%: 98.13%–102.42% for AUCplt and 97.56%–105.80% for Pmax. The pharmacokinetic profiles of GP40141 and the reference romiplostim were well described. No adverse events were observed during the clinical trial after the administration of GP40141 and the reference romiplostim. Conclusion This study demonstrates the PD similarity of GP40141 to the reference romiplostim. Both treatments had comparable safety profiles (NCT05652595)https://doi.org/10.1002/prp2.1125biosimilarityGP40141pharmacodynamicspharmacokineticsromiplostim |
| spellingShingle | Igor Makarenko Artem Dorotenko Sergey Noskov Veniamin Banko Valeria Saparova Alexandr Khokhlov Evgeniia Zoreeva Andrey Nedorubov Bella Zinnatulina Maria Gefen Roman Drai A randomized, double‐blind, comparative study of the pharmacodynamics and pharmacokinetics of GP40141 (romiplostim biosimilar) and reference romiplostim in healthy male volunteers Pharmacology Research & Perspectives biosimilarity GP40141 pharmacodynamics pharmacokinetics romiplostim |
| title | A randomized, double‐blind, comparative study of the pharmacodynamics and pharmacokinetics of GP40141 (romiplostim biosimilar) and reference romiplostim in healthy male volunteers |
| title_full | A randomized, double‐blind, comparative study of the pharmacodynamics and pharmacokinetics of GP40141 (romiplostim biosimilar) and reference romiplostim in healthy male volunteers |
| title_fullStr | A randomized, double‐blind, comparative study of the pharmacodynamics and pharmacokinetics of GP40141 (romiplostim biosimilar) and reference romiplostim in healthy male volunteers |
| title_full_unstemmed | A randomized, double‐blind, comparative study of the pharmacodynamics and pharmacokinetics of GP40141 (romiplostim biosimilar) and reference romiplostim in healthy male volunteers |
| title_short | A randomized, double‐blind, comparative study of the pharmacodynamics and pharmacokinetics of GP40141 (romiplostim biosimilar) and reference romiplostim in healthy male volunteers |
| title_sort | randomized double blind comparative study of the pharmacodynamics and pharmacokinetics of gp40141 romiplostim biosimilar and reference romiplostim in healthy male volunteers |
| topic | biosimilarity GP40141 pharmacodynamics pharmacokinetics romiplostim |
| url | https://doi.org/10.1002/prp2.1125 |
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