在健康成人中对通过自动注射器、预灌装注射器或小瓶和注射器给药的即用、室温、液态稳定胰高血糖素进行的双向交叉 1 期生物等效性和安全性研究。

IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM Journal of Diabetes Science and Technology Pub Date : 2024-11-01 Epub Date: 2023-06-08 DOI:10.1177/19322968231179164
M Khaled Junaidi, Matthew R Krecic, Nicole C Close, Valentina Conoscenti
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引用次数: 0

摘要

目的证明通过胰高血糖素自动注射器(GAI)或胰高血糖素瓶和注射器套件(GVS)皮下注射(SC)的即用型室温液态稳定胰高血糖素与胰高血糖素预充注射器(G-PFS)的生物等效性和安全性。方法:将健康成人(32 人)随机分配到接受 1 毫克胰高血糖素 GAI 或 G-PFS,然后在三到七天后作为替代方案。其他健康成人(N = 40)被随机分配接受 1 毫克胰高血糖素作为 GVS 或 G-PFS,两天后再作为替代方案。在注射胰高血糖素 240 分钟后采集血浆胰高血糖素样本。当治疗组之间血浆胰高血糖素的 0 至 240 分钟浓度-时间曲线下面积(AUC0-240)和最大浓度(Cmax)的几何平均估计比值控制在 80% 和 125% 的范围内时,即宣布生物等效性。记录了不良事件(AEs):G-PFS与GAI、GVS与G-PFS的AUC0-240和Cmax几何平均比的90%置信区间(CIs)在80%至125%范围内(G-PFS:GAI AUC0-240 95.05%、119.67%,Cmax 88.01%、120.24%;GVS:G-PFS AUC0-240 87.39%、100.66%,Cmax 89.08%、106.08%)。15.6%(5/32)的 GAI 参与者、25%(18/72)的 G-PFS 参与者和 32.5%(13/40)的 GVS 参与者至少发生过一次 AE。73 例 AE 中有 69 例(94.5%)为轻度 AE,无严重 AE。最常见的是恶心(33/73 [45%]):结论:通过自动注射器、预灌装注射器或小瓶和注射器套件,健康成人经皮下注射 1 毫克这种即用型室温液态稳定胰高血糖素后,其生物等效性和安全性得到了证实。
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Two-Way Crossover Phase 1 Bioequivalence and Safety Studies in Healthy Adults for a Ready-to-Use, Room-Temperature, Liquid-Stable Glucagon Administered by Autoinjector, Prefilled Syringe, or Vial and Syringe.

Objective: To demonstrate bioequivalence and safety for a ready-to-use room-temperature liquid-stable glucagon administered subcutaneously (SC) through a glucagon autoinjector (GAI) or a glucagon vial and syringe kit (GVS), versus a glucagon prefilled syringe (G-PFS).

Methods: Healthy adults (N = 32) were randomly assigned to receive 1-mg glucagon as GAI or G-PFS, and then as the alternative three to seven days later. Other healthy adults (N = 40) were randomly assigned to receive 1-mg glucagon as GVS or G-PFS, and then as the alternative two days later. Samples for plasma glucagon were obtained through 240 minutes after glucagon injection. Bioequivalence was declared when the geometric mean estimate ratio of the area under-the-concentration-versus-time curve from 0 to 240 minutes (AUC0-240) and maximum concentration (Cmax) for plasma glucagon between treatment groups was contained within the bounds of 80% and 125%. Adverse events (AEs) were recorded.

Results: The 90% confidence intervals (CIs) for AUC0-240 and Cmax geometric mean ratios for G-PFS to GAI and GVS to G-PFS were contained within the bounds 80% to 125% (G-PFS:GAI AUC0-240 95.05%, 119.67% and Cmax 88.01%, 120.24%; GVS:G-PFS AUC0-240 87.39%, 100.66% and Cmax 89.08%, 106.08%). At least one AE occurred in 15.6% (5/32) participants with GAI, 25% (18/72) with G-PFS, and 32.5% (13/40) with GVS. Sixty-nine of 73 (94.5%) AEs were mild, and none were serious. Nausea was the most common (33/73 [45%]).

Conclusions: Bioequivalence and safety were established after 1 mg of this ready-to-use room-temperature liquid-stable glucagon, administered SC to healthy adults, by autoinjector, prefilled syringe, or vial and syringe kit.

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来源期刊
Journal of Diabetes Science and Technology
Journal of Diabetes Science and Technology Medicine-Internal Medicine
CiteScore
7.50
自引率
12.00%
发文量
148
期刊介绍: The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society. JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cybersecurity, software for modeling, physiologic monitoring, technology for managing obesity, and diagnostic tests of glycation. The journal also covers the development and use of mobile applications and wireless communication, as well as bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes.
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