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| Name | Class |
|---|---|
| Profil Institut für Stoffwechselforschung GmbH | INDUSTRY |
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Single-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover,12-hour euglycaemic glucose clamp trial in healthy subjects
The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin R with Humulin® R 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 each dosing.
The planned trial duration for each subject is about 12 to 36 days. Eligible subjects will undergo two 12-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 R | Experimental | 0.3 IU/kg Dose per administration, subcutaneous Route of administration |
|
| Humulin® R (regular insulin human) | Active Comparator | 0.3 IU/kg Dose per administration, subcutaneous Route of administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biocon Insulin R | Biological | Biocon Insulin R is a short-acting human insulin, produced by recombinant deoxyribonucleic acid (rDNA) technology utilizing Pichia pastoris (yeast). |
| Measure | Description | Time Frame |
|---|---|---|
| PK endpoints:Area under the insulin concentration curve(AUCins).0-12h | Area under the insulin concentration curve from 0 to 12 hours. | 0-12 hours |
| PD endpoints: Area under the glucose infusion rate curve(AUCGIR).0-12h | Area under the glucose infusion rate curve | 0-12 hours |
| PK endpoints: Maximum observed insulin concentration(Cins.max) | Maximum observed insulin concentration | 0-12 hours |
| PD endpoints:maximum glucose infusion rate(GIRmax) | maximum glucose infusion rate | 0-12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| PK endpoint- Area under the insulin concentration curve(AUCins).0-2h | Area under the insulin concentration curve | 0 to 2 hours |
| PK 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 |
|---|---|---|
| Dr. Leona P Mörschel | Profil Mainz GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Mainz GmbH | Mainz | Germany |
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Double-blind
| Humulin®R | Biological | Humulin® R is a polypeptide hormone structurally identical to human insulin synthesised through recombinant deoxyribonucleic acid (rDNA) technology in a non-pathogenic laboratory strain of Escherichia coli bacteria. |
|
area under the insulin concentration curve
| 0 to 6 hours |
| PK endpoint- Area under the insulin concentration curve(AUCins).6-12h | area under the insulin concentration curve | 6 to 12 hours |
| PK endpoint- Area under the insulin concentration curve(AUCins).0-infinity | area under the insulin concentration-time curve | 0 hours to 24 hours |
| PK endpoint- time to maximum concentration( tmax) | time to maximum observed insulin concentration. | 0-12 hours |
| PK endpoint- time(t)50%-ins(early) | time to half-maximum before Cins.max. | 0-12 hours |
| PK endpoint- time(t)50%-ins(late) | time to half-maximum after Cins.max. | 0-12 hours |
| PK endpoint- terminal elimination half-life (t½) | terminal elimination half-life calculated as t½=ln2/λz. | 0-12 hours |
| PK endpoint- terminal elimination rate constant (λz) | terminal elimination rate constant of insulin. | 0-12 hours |
| PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-2h | area under the glucose infusion rate curve | 0 to 2 hours |
| PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-6h | area under the glucose infusion rate curve | 0 to 6 hours |
| PD endpoint: area under the glucose infusion rate curve(AUCGIR).6-12h | area under the glucose infusion rate curve | 6 to 12 hours |
| PD endpoint: time to maximum glucose infusion rate (tGIR.max) | time to maximum glucose infusion rate | 0-12 hours |
| PD endpoint: time to half-maximum glucose infusion rate before GIRmax (tGIR,50%-early | time to half-maximum glucose infusion rate before GIRmax | 0-12 hours |
| PD endpoint: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) | 0-12 hours |
| PD endpoint: Onset of action | ime 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) | 0-12 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 to Follow-up period (Total duration: 35 days approximate) |