Study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(L), US-Humalog®, and EU-Humalog®
A single center, single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(L), US-Humalog®, and EU-Humalog® using the euglycemic clamp technique in healthy male adult volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
54
Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.
Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.
Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.
FARMOVS
Bloemfontein, South Africa
To compare the pharmacokinetics (PK) of NKF-INS Lispro(L) to United States (US)-approved and European Union (EU)-authorized Humalog to demonstrate PK similarity for insulin lispro
Lispro concentration time curve from 0 to 12 hours
Time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first
To compare the pharmacokinetics (PK) of NKF-INS Lispro(L) to United States (US)-approved and European Union (EU)-authorized Humalog to demonstrate PK similarity for insulin lispro
Maximum observed insulin lispro concentration (Cmax)
Time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first
To compare the pharmacodynamics (PD) of NKF-INS(L) to US-approved and EU-authorized Humalog by examining GIR profiles after a single subcutaneous (SC) dose.
Area under the Glucose Infusion Rate (GIR)-time curve from 0 to 12 hours
Time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first
To compare the pharmacodynamics (PD) of NKF-INS(L) to US-approved and EU-authorized Humalog by examining GIR profiles after a single subcutaneous (SC) dose.
Maximum GIR (GIRmax) of glucose.
Time frame: Baseline to 720 minutes or the end of clamp procedure, whichever occurs first
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