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| Name | Class |
|---|---|
| Profil Institut für Stoffwechselforschung GmbH | INDUSTRY |
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Two-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover, 24-hour euglycaemic glucose clamp trial in healthy subjects.
The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin 70/30 with Humulin® 70/30 in healthy subjects The treatment consists of one single dose of the test or reference product, administered during each of the two study periods, separated by 5-7 days between dosing. The planned trial duration for each subject is about 12 to 36 days.
Eligible subjects will undergo two 24-hour euglycaemic clamp examinations, one after administration of the test product and one after administration of the reference product in random order.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biocon Insulin 70/30 | Experimental | 0.4 IU/kg Dose per administration, Subcutaneous Route of administration |
|
| Humulin® 70/30 | Active Comparator | 0.4 IU/kg Dose per administration, Subcutaneous Route of administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humulin ®70/30 | Biological | Humulin® 70/30 is a premixed suspension of human insulin of recombinant deoxyribonucleic acid (rDNA)origin, which contains 30% short-acting human soluble insulin and 70% intermediate-acting isophane insulin. Human insulin is produced by recombinant deoxyribonucleic acid (rDNA), technology utilizing a non-pathogenic laboratory strain of Escherichia coli. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic endpoints: area under the insulin concentration curve (AUCins) 0-24h | area under the insulin concentration curve | 0-24hour |
| Pharmacokinetic endpoints: insulin concentration (Cins).max | maximum observed insulin concentration. | 0-24hour |
| Pharmacodynamic Endpoint: Area under curve (AUC)Glucose infusion rate (GIR).0-24h | area under the glucose infusion rate curve | 0-24hour |
| Pharmacodynamic Endpoint: maximum glucose infusion rate (GIRmax) | maximum glucose infusion rate | 0-24hour |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins) 0-2h | area under the insulin concentration curve | 0-2hour |
| Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins) 0-6h |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints: Number of subjects with Adverse Events, clinically significant changes in Physical examination, Vital signs. Local tolerability/ Injection site reactions | Number of subjects with Adverse Events, clinically significant changes in Physical examination, Vital signs Local tolerability/ Injection site reactions | First dose to followup period (Total duration: 14 days approximate) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oliver Klein, MD | Profil Institut für Stoffwechselforschung GmbH Hellersbergstr. 9 D-41460 Neuss | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Mainz GmbH & Co. KG Malakoff-Passage,Rheinstraße 4C D-55116 | Mainz | Germany | ||||
| Profil Institut für Stoffwechselforschung GmbH Hellersbergstr. 9 D-41460 Neuss |
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Double-blind
|
| Biocon Insulin 70/30 | Biological | Biocon Insulin 70/30 is a premixed suspension of human insulin of recombinant deoxyribonucleic acid (rDNA)origin, which contains 30% short-acting human soluble insulin and 70% intermediate-acting isophane insulin. Biocon insulin is produced by recombinant deoxyribonucleic acid (rDNA) technology utilizing a non-pathogenic laboratory strain of Escherichia coli. |
|
area under the insulin concentration curve
| 0-6hour |
| Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins) 0-12h | area under the insulin concentration curve | 0-12hour |
| Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins)12-24h | area under the insulin concentration curve | 12-24hour |
| Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins).0-infinity | area under the insulin concentration curve | 0 to 24 hours |
| Pharmacokinetic endpoint: time to maximum observed insulin concentration (tmax) | time to maximum observed insulin concentration | 0-24hour |
| Pharmacokinetic endpoint: time(t)50%-ins(early) | time to half-maximum before Cins.max | 0-24hour |
| Pharmacokinetic endpoint: time(t)50%-ins(late) | time to half-maximum after Cins.max | 0-24hour |
| Pharmacokinetic endpoint: terminal elimination half-life (t½) | terminal elimination half-life calculated as t½=ln2/λz | 0-24hour |
| Pharmacokinetic endpoint:terminal elimination rate constant(λz) | terminal elimination rate constant of insulin | 0-24hour |
| Pharmacodynamic endpoints: area under the glucose infusion rate curve (AUCGIR) 0-2h | area under the glucose infusion rate curve | 0-2hour |
| Pharmacodynamic endpoints: area under the glucose infusion rate curve (AUCGIR)0-6h | area under the glucose infusion rate curve | 0-6hour |
| Pharmacodynamic endpoints: area under the glucose infusion rate curve(AUCGIR)0-12h | area under the glucose infusion rate curve | 0-12hour |
| Pharmacodynamic endpoints: area under the glucose infusion rate curve (AUCGIR)12-24h | area under the glucose infusion rate curve | 12-24hour |
| Pharmacodynamic endpoints: time to maximum glucose infusion rate (tGIR.max) | time to maximum glucose infusion rate | 0-24hour |
| Pharmacodynamic endpoints: time to half-maximum glucose infusion rate before GIRmax(tGIR.50%-early) | time to half-maximum glucose infusion rate before Maximum glucose infusion rate(GIRmax) | 0-24hour |
| Pharmacodynamic endpoints: time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late) | time to half-maximum glucose infusion rate after Maximum glucose infusion rate(GIRmax) | 0-24hour |
| Pharmacodynamic endpoints: 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). | 0-24hour |
| 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: 35 days approximate) |
| Neuss |
| Germany |