Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects
Фаза 1
Завершено
NCT02453672
| Заболевание | Healthy |
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| Фаза | Фаза 1 |
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| Спонсор | Samsung Bioepis Co., Ltd. |
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| Статус | Завершено |
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| Участники | 119 участн. |
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| Вмешательство | SB8, EU sourced Avastin®, US Sourced Avastin® |
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| Дата начала | 04.2015 |
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| Дата завершения | 09.2015 |
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| Публикация результатов | 3.06.2019 |
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Кратко
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
0 to 2016 hours after start of infusion · h·μg/mL
| SB8 (Proposed Bevacizumab Biosimilar) | 25354.4 ± 4833.10 h·μg/mL |
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| EU Sourced Avastin® | 28896.8 ± 6221.62 h·μg/mL |
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| US Sourced Avastin® | 28684.8 ± 5425.14 h·μg/mL |
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Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
0 to 2016 hours after start of infusion · h·μg/mL
| SB8 (Proposed Bevacizumab Biosimilar) | 24199.2 ± 4367.53 h·μg/mL |
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| EU Sourced Avastin® | 27342.2 ± 5374.53 h·μg/mL |
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| US Sourced Avastin® | 27177.9 ± 4770.93 h·μg/mL |
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Maximum Serum Concentration (Cmax)
0 to 2016 hours after start of infusion · μg/mL
| SB8 (Proposed Bevacizumab Biosimilar) | 76.259 ± 14.6999 μg/mL |
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| EU Sourced Avastin® | 76.059 ± 11.7053 μg/mL |
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| US Sourced Avastin® | 76.485 ± 16.9916 μg/mL |
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