Single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS Glargine (G), United States (US)-Lantus®, and European Union (EU)-Lantus®
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(G), US-Lantus®, and EU-Lantus® using the euglycemic clamp technique in healthy male adult volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
114
Single subcutaneous dose of 0.5 IU/kg administered over three periods
Single subcutaneous dose of 0.5 IU/kg administered over three periods
Single subcutaneous dose of 0.5 IU/kg administered over three periods
FARMOVS Clinical Research Organisation
Bloemfontein, South Africa
To compare the Pharmacokinetic (PK) of NKF-INS Glargine(G) to United States (US)-approved and European Union (EU)-authorized Lantus to demonstrate PK similarity for metabolite 21A-Gly-human insulin (M1)
Area Under the Curve (AUC)0-24h of M1
Time frame: 60 and 0 minutes pre-dose and 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours post-dose
To evaluate additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for insulin glargine
PK parameters for plasma insulin glargine concentrations and/or M1: maximum observed plasma exogenous insulin glargine concentration.
Time frame: 60 and 0 minutes pre-dose and 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours post-dose
To evaluate additional PK parameters of NKF-INS(G), US-approved and EU-authorized Lantus to demonstrate similarity for M1
M1: maximum observed plasma exogenous insulin glargine concentration (Cmax), AUC0-24h, AUC0-6h, AUC6-12h, AUC0-12h, AUC12-18h, AUC18-24h, and AUC12-24h (fractional area under the plasma concentration-time curve), time to maximum plasma exogenous insulin glargine concentration (Tmax), AUC0-∞
Time frame: 60 and 0 minutes pre-dose and 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours post-dose
To compare the Pharmacodynamic (PD) of NKF-INS(G) to US-approved and EU-authorized Lantus by examining glucose infusion rate (GIR) profiles after a single subcutaneous (SC) dose.
GIRAUC0-24h, GIRAUC0-end of clamp, GIRAUC0-∞, GIRAUC0-6h, GIRAUC6-12h, GIRAUC0-12h, GIRAUC12-18h, GIRAUC18-24h, and GIRAUC12-24h (fractional area under the GIR-time curve), GIRmax, Total(T)GIRmax, and total amount of glucose infused during clamp procedure (Gtot)
Time frame: Time Frame: 60 and 0 minutes pre-dose and 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours post-dose
To assess the safety of NKF-INS(G)
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Adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Day 1 to 7 weeks