A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide
- Registration Number
- NCT04228354
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body mass index between 20.0 and 27.0 kg/m^2 (both inclusive).
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
- Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Semaglutide 0.68 mg/mL Semaglutide Semaglutide administered with the PDS290 pen-injector Semaglutide 1.0 mg/mL Semaglutide Semaglutide administered with the PDS290 pen-injector
- Primary Outcome Measures
Name Time Method Maximum semaglutide plasma concentration 0-840 hours nmol/L
Area under the semaglutide plasma concentration curve from 0 to tz 0-840 hours h\*nmol/L
- Secondary Outcome Measures
Name Time Method Time to Cmax for semaglutide 0-840 hours h
Terminal elimination half-life 0-840 hours h
Total apparent clearance of semaglutide 0-840 hours L/h
Area under the semaglutide plasma concentration curve 0-840 hours h\*nmol/L
Apparent volume of distribution of semaglutide 0-840 hours L
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Neuss, Germany