This trial is conducted in Europe. The aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with identical active ingredient in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Subject will receive a single injection (s.c.) of IDegLira B5
Subject will receive a single injection (s.c.) of IDegLira V2
Unnamed facility
Neuss, Germany
Area under the serum IDeg concentration time curve after single dose
Time frame: Assessed from 0 to 120 hours
Maximum observed serum IDeg concentration after single dose
Time frame: Assessed from 0-120 hours
Area under the plasma liraglutide concentration time curve after single dose
Time frame: Assessed from 0-72 hours
Maximum observed plasma liraglutide concentration after single dose
Time frame: Assessed from 0-72 hours
Area under the serum IDeg concentration time curve after single dose
Time frame: Assessed from 0-120 hours
Time to maximum IDeg concentration
Time frame: Assessed from 0-120 hours
Terminal elimination half-life for IDeg after single dose
Time frame: Assessed from 0-120 hours
Area under the plasma liraglutide concentration time curve after single dose
Time frame: Assessed from 0-72 hours
Time to maximum plasma liraglutide concentration after single dose
Time frame: Assessed from 0-72 hours
Terminal elimination half-life of liraglutide after single dose
Time frame: Assessed from 0-72 hours
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