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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
For subcutaneous (s.c., under the skin), single dose administration at two separate dosing visits.
Unnamed facility
Berlin, Germany
Area under the plasma semaglutide concentration curve
Time frame: 0-4 weeks after a single dose s.c. semaglutide administration
Cmax, the maximum plasma semaglutide concentration
Time frame: 20-40 hours after a single dose s.c. semaglutide administration
The area under the plasma semaglutide concentration curve
Time frame: From time 0 to infinity after a single dose s.c. semaglutide administration
tmax, time to Cmax of semaglutide
Time frame: 20-40 hours
t½, terminal elimination half-life of semaglutide
Time frame: 140-200 hours
Incidence of adverse events (AEs)
Time frame: From first dosing to follow-up (5-7 weeks after the second dosing)
Hypoglycaemic episodes
Time frame: From first dosing to follow-up (5-7 weeks after the second dosing)
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