A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes
NCT01766245 · Completed
Last updated 2026-05-28This clinical trial tested whether two versions of semaglutide, a diabetes medication given by injection, are absorbed similarly in the bloodstream of healthy volunteers.
Status Completed The study has finished.
Phase Phase 1 Checks safety and dosing in a small group.
Type Interventional (clinical trial)
Design Randomized, double-blind treatment study
Participants 28 people
Who can join Ages 18–55 · all sexes Healthy volunteers accepted.
Timeline Started 2012-12 · est. completion 2013-05
Where 1 site · Germany
What this study is testing ClinicalTrials.gov NCT01766245 ↗
Description as written by the study sponsor.
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between subcutaneous injections of semaglutide produced by two manufacturing processes.
Treatments tested
- semaglutide Drug
For subcutaneous (s.c., under the skin), single dose administration at two separate dosing visits.
| Main thing measured | Area under the plasma semaglutide concentration curve |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Conditions studied | Diabetes, Healthy |
| GLP-1 drugs | semaglutide |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01766245 ↗