دورية
A randomized, double-blind, parallel pharmacokinetic study comparing the trastuzumab biosimilar candidate, AryoTrust®, and reference trastuzumab in healthy subjects
| العنوان: | A randomized, double-blind, parallel pharmacokinetic study comparing the trastuzumab biosimilar candidate, AryoTrust®, and reference trastuzumab in healthy subjects |
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| المؤلفون: | Farmahini Farahani, Mohammad, Maghzi, Parnian, Jafari Aryan, Nazanin, Payandemehr, Borna, Soni, Mayur, Azhdarzadeh, Morteza |
| المصدر: | Expert Opinion on Investigational Drugs; December 2020, Vol. 29 Issue: 12 p1443-1450, 8p |
| مستخلص: | ABSTRACTBackgroundAryoTrust® (AryoGen Pharmed Co., Iran) is a biosimilar candidate for the EU-sourced reference trastuzumab, Herceptin®. This study was designed to evaluate the bioequivalence between AryoTrust® and Herceptin®.Research design and methodsIn this double-blind, parallel study, 60 healthy male subjects were randomized 1:1 to receive a single dose of AryoTrust® or Herceptin® (6 mg/kg) as intravenous infusion. The primary endpoint of the study was the area under the concentration versus time to infinity (AUC0-inf), and the main secondary endpoints were maximum measured concentration (Cmax), area under the concentration versus time from zero to the last quantifiable concentration time (AUC0-last), immunogenicity, and safety.ResultsSixty subjects were enrolled in the study and baseline demographics were similar between the two groups. The two groups demonstrated similar pharmacokinetic parameters and the 90% confidence interval (CI) for primary and secondary endpoints were within the bioequivalence acceptance range (80.00%–125.00%). No serious adverse event or immunogenicity was reported, and all of the adverse events reported were mild and similar between the two treatment groups.ConclusionAryoTrust® was well tolerated, had a similar safety profile to reference trastuzumab, and its pharmacokinetic bioequivalence was confirmed.Trial registrationThe trial is registered at Indian Trials Registry (CTRI/2019/03/018218) |
| قاعدة البيانات: | Supplemental Index |
PDF full text from Publisher | تدمد: | 13543784 17447658 |
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| DOI: | 10.1080/13543784.2020.1831470 |