To improve ease of use and convenience for subjects, Novo Nordisk is developing a single dose pen-injector with an integrated prefilled syringe for semaglutide s.c. referred to as DV3396 pen-injector. In order to generate clinical trial data with the DV3396 pen-injector, all.
Semaglutide (administered by DV3396 pen-injector) and ... - ICH …
2020年1月22日 · Participants will get the medicine as an injection under the skin of the belly with a pen-injector. The type of pen-injector is different for the 2 versions of semaglutide. Participants will receive 7 once-weekly injections in total.
Semaglutide（由 DV3396 笔式注射器给药） 和 ... - ICH GCP
2020年1月22日 · 皮下注射 2 mg Semaglutide 后用于 DV3396 笔式注射器的 Semaglutide D 制剂与用于 PDS290 笔式注射器的制剂之间生物等效性的试验. 该研究将研究 2 种不同的 semaglutide 版本在注射后如何到达并留在血液中。 该研究旨在显示使用不同版本的 semaglutide 时血液中 semaglutide 的相似水平。 参与者将获得 semaglutide 的 2 个版本中的 1 个——哪个版本由偶然决定。 一个版本是医生已经可以开的那个，另一个是新版本。 参与者将使用笔式注射器在腹部 …
Semaglutide (administered by DV3396 pen) and Semaglutide
2019年7月5日 · Participants will get the medicine as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject themselves with the medicine.
A Research Study to Compare Two Different Forms of Once …
Participants will receive once-weekly doses of semaglutide administered with the DV3396 pen-injector (test drug product)
A Trial to Demonstrate Bioequivalence Between Semaglutide
A Trial to Demonstrate Bioequivalence Between Semaglutide Formulation D With the DV3396 Pen-injector and Formulation B With the PDS290 Pen-injector in Subjects With Overweight or Obesity Status: Completed
A Research Study to Compare Two Forms of Semaglutide in Two …
Participants will get the medicine as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject themselves with the medicine.
Evaluating the usability and safety of the semaglutide single‐dose pen …
2020年10月8日 · A single-dose, shield-activated pen-injector for each of the three approved dose variants (0.25, 0.5 and 1 mg) of once-weekly subcutaneous semaglutide has been developed to improve usability. This su...
Semaglutide in Diabetes Mellitus, Type 2 - ICH GCP
2019年11月4日 · A Trial to Demonstrate Bioequivalence Between Semaglutide D Formulations for the DV3396 Pen-Injector and the Formulation for the PDS290 Semaglutide Pen-Injector. The study will look at how two different semaglutide versions reach and stay in …
A Study Comparing the Injection Site Pain Experience After the ...
This study in healthy men and women looks at the injection site experience of the DV3396 pen to that of the PDS290 pens when both pens are used to deliver 0.25 mg semaglutide subcutaneously (s.c., under the skin). Participants will receive 2 single doses of …