This trial is conducted i Europe. The aim of this trial is to test for bioequivalence between two explorative formulations of insulin degludec (insulin 454) and between two explorative insulin degludec/insulin aspart (IDegAsp - formerly SIAC) formulations, all with or without buffer, in healthy male subjects. The investigated formulations are explorative, not similar to the proposed commercial formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
58
Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin).
Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin).
Unnamed facility
Neuss, Germany
Area under the serum insulin degludec concentration-time curve (for insulin degludec)
Time frame: 0-120 hours after dosing
Maximum serum insulin degludec concentration (Cmax) (for insulin degludec)
Time frame: 0-120 hours after dosing
Area under the serum insulin aspart concentration-time curve (for IDegAsp)
Time frame: 0-10 hours after dosing
Maximum serum insulin aspart concentration (Cmax) (for IDegAsp)
Time frame: 0-10 hours after dosing
Area under the serum insulin degludec concentration-time curve (for IDegAsp)
Time frame: 0-120 hours after dosing
Maximum serum insulin degludec concentration (Cmax) (for IDegAsp)
Time frame: 0-120 hours after dosing
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