Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects
The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin N with Humulin® N in healthy subjects. The treatment consists of one single dose of the test or reference product, administered during each of the three study periods, separated by 5-7 days between each dosing. The planned trial duration for each subject is about 17 to 43 days. Eligible subjects will undergo three euglycaemic clamp examinations (each of 24 hours duration). Depending on the sequence in which a particular subject is randomized, each subject will either undergo two clamps with administration of test product plus one clamp with administration of reference product, or, two clamps with administration of reference product plus one clamp with administration of test product, in random order.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
90
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Humulin® N (human insulin \[recombinant deoxyribonucleic acid origin\] isophane suspension) is an intermediate-acting human isophane insulin. Humulin® N is a suspension of crystals produced from combining human insulin and protamine sulphate.
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Primary PK endpoint: area under the insulin concentration curve(AUCins).0-24h
area under the insulin concentration curve
Time frame: 0-24hour
Primary PK endpoint: maximum observed insulin concentration(Cins.max)
maximum observed insulin concentration
Time frame: 0-24hour
PD endpoint:area under the glucose infusion rate curve(AUCGIR)0-24h
area under the glucose infusion rate curve
Time frame: 0-24hour
PD endpoint:maximum observed glucose infusion rate (GIRmax)
maximum observed glucose infusion rate
Time frame: 0-24hour
Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-infinity
area under the insulin concentration-time curve
Time frame: 0-24 hours
Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-12h
area under the insulin concentration-time curve
Time frame: 0-12hour
Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).12-24h
area under the insulin concentration-time curve
Time frame: 12-24hour
Secondary PK endpoint:time to maximum observed insulin concentration (tmax.ins)
time to maximum observed insulin concentration
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Time frame: 0-24 hours
Secondary PK endpoint:terminal elimination rate constant of insulin (λz)
terminal elimination rate constant of insulin
Time frame: 0-24 hours
Secondary PK endpoint: terminal elimination half-life (t½)
terminal elimination half-life calculated as t½=ln2/λz
Time frame: 0-24 hours
Secondary PK endpoint: time(t)50%-INS(early)
time to half-maximum before Cmax
Time frame: 0-24 hours
Secondary PK endpoint: time(t)50%-INS(late)
time to half-maximum after Cmax
Time frame: 0-24 hours
Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).0-12h
areas under the glucose infusion rate curve
Time frame: 0-12hours
Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h
areas under the glucose infusion rate curve
Time frame: 12-24hours
Secondary PD endpoint: time to maximum glucose infusion rate(tmax.GIR)
time to maximum glucose infusion rate
Time frame: 0-24 hours
Secondary PD endpoint:time to half-maximum glucose infusion rate before GIRmax (tGIR.50%-early)
time to half-maximum glucose infusion rate before GIRmax
Time frame: 0-24 hours
Secondary PD endpoint: time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late)
time to half-maximum glucose infusion rate after GIRmax
Time frame: 0-24 hours
Secondary PD endpoint: Onset of action
time from trial product administration until blood glucose concentration has decreased at least 5 mg/dL from baseline, where baseline is defined as the mean of blood glucose levels from -6, -4, and -2 minutes before trial product administration as measured by ClampArt(name of Clamp Devise))
Time frame: 0-24 hours