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| Name | Class |
|---|---|
| Profil Institut für Stoffwechselforschung GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence: Humulin® N- Biocon Insulin N-Humulin® N | Experimental | Period 1: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days |
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| Sequence: Biocon Insulin N- Humulin® N- Humulin® N | Experimental | Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Humulin® N(100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days |
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| Sequence: Humulin® N- Humulin® N-Biocon Insulin N | Experimental | Period 1: 0.4 IU/kg of Humulin® N(100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days |
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| Sequence: Biocon Insulin N- Humulin® N- Biocon Insulin N | Experimental | Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biocon Insulin N | Biological | Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast). |
| Measure | Description | Time Frame |
|---|---|---|
| Primary PK endpoint: area under the insulin concentration curve(AUCins).0-24h | area under the insulin concentration curve | 0-24hour |
| Primary PK endpoint: maximum observed insulin concentration(Cins.max) | maximum observed insulin concentration | 0-24hour |
| PD endpoint:area under the glucose infusion rate curve(AUCGIR)0-24h | area under the glucose infusion rate curve | 0-24hour |
| PD endpoint:maximum observed glucose infusion rate (GIRmax) | maximum observed glucose infusion rate | 0-24hour |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-infinity | area under the insulin concentration-time curve | 0-24 hours |
| Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-12h |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint: Number of subjects with Adverse Events (AEs), clinically significant changes in Physical examination, Vital signs. Local tolerability/ Injection site reactions | Number of subjects with Adverse Events (AEs), clinically significant changes in Physical examination, Vital signs. Local tolerability/ Injection site reactions | First dose to followup period (Total duration: 21 days approximate) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Grit Andersen | Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9] | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | Germany |
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Partially replicated design, crossover trial
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Double blind study
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| Sequence: Humulin® N-Biocon Insulin N- Biocon Insulin N | Experimental | Period 1: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days |
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| Sequence: Biocon Insulin N- Biocon Insulin N-Humulin® N | Experimental | Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days |
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| Humulin® N | Biological | 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. |
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area under the insulin concentration-time curve
| 0-12hour |
| Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).12-24h | area under the insulin concentration-time curve | 12-24hour |
| Secondary PK endpoint:time to maximum observed insulin concentration (tmax.ins) | time to maximum observed insulin concentration | 0-24 hours |
| Secondary PK endpoint:terminal elimination rate constant of insulin (λz) | terminal elimination rate constant of insulin | 0-24 hours |
| Secondary PK endpoint: terminal elimination half-life (t½) | terminal elimination half-life calculated as t½=ln2/λz | 0-24 hours |
| Secondary PK endpoint: time(t)50%-INS(early) | time to half-maximum before Cmax | 0-24 hours |
| Secondary PK endpoint: time(t)50%-INS(late) | time to half-maximum after Cmax | 0-24 hours |
| Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).0-12h | areas under the glucose infusion rate curve | 0-12hours |
| Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h | areas under the glucose infusion rate curve | 12-24hours |
| Secondary PD endpoint: time to maximum glucose infusion rate(tmax.GIR) | time to maximum glucose infusion rate | 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 | 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 | 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)) | 0-24 hours |
| Safety endpoint: Number of subjects with clinically significant changes in Laboratory safety parameters, Electrocardiogram (ECG) | Number of subjects with clinically significant changes in Laboratory safety parameters. Number of subjects with clinically significant changes in Electrocardiogram (ECG) | Screening and Follow-up period (Total duration: 42 days approximate) |