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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's Human Insulin R U-500 with Humulin® R U-500 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 18 to 44 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: Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500- Humulin® R U-500 | Experimental | Period 1:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe |
|
| Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500- Humulin® R U-500 | Experimental | Period 1:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe |
|
| Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500 | Experimental | Period 1:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biocon's Human Insulin R U-500 | Biological | Biocon's Human Insulin R U-500 (Insulin Human Injection 500 units/mL), 3 mL cartridges (containing 1,500 units of insulin). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary pharmacokinetics (PK) endpoint: area under the insulin concentration curve(AUCins).0-12h | Area under the insulin concentration curve | 0 to12 hours |
| Primary pharmacokinetics (PK) endpoint: maximum observed insulin concentration(Cins.max) | Maximum observed insulin concentration | NAP (Not Applicable) |
| Primary pharmacodynamics (PD) endpoint:area under the glucose infusion rate curve (AUCGIR)0-12h | Area under the glucose infusion rate curve | 0 to 12 hours |
| Primary pharmacodynamics (PD) endpoint:maximum observed glucose infusion rate (GIRmax) | Maximum observed glucose infusion rate | NAP (Not Applicable) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve(AUCins).0-infinity | Area under the insulin concentration-time curve | 0 hours to 24 hours |
| Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve(AUCins).0-24h |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint: Number of subjects with Adverse Events (AEs) | Signing of Informed consent form (ICF) to follow-up period (Total duration: 44 days approximate) | |
| Safety endpoint: Number of subjects with Clinically significant changes in Physical examination | Signing of Informed consent form (ICF) to follow-up period (Total duration: 44 days approximate) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Ulrike Hövelmann, MD | Profil Institut für Stoffwechselforschung GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH 9 | Neuss | D-41460 | Germany |
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Partially replicated design, crossover trial
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Double-blind
| Sequence: Humulin® R U-500-Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500 | Experimental | Period 1:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe |
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| Sequence: Humulin® R U-500 -Biocon's Human Insulin R U-500-Humulin® R U-500 | Experimental | Period 1:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe |
|
| Sequence: Humulin® R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500 | Experimental | Period 1:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD(Becton Dickinson) disposable syringe Period 3:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe |
|
| Humulin® R U-500 (US Reference Product) | Biological | Humulin® R U-500 (US Reference Product), 3 mL single-patient-use KwikPen® (containing 1,500 units of insulin) |
|
Area under the insulin concentration-time curve |
| 0 to 24 hours |
| Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve (AUCins).12-24h | Area under the insulin concentration-time curve | 12 to 24 hours |
| Secondary pharmacokinetics (PK) endpoint:time to maximum observed insulin concentration (tmax.ins) | Time to maximum observed insulin concentration | 0 to 24 hours |
| Secondary pharmacokinetics (PK) endpoint:terminal elimination rate constant of insulin (λz) | Terminal elimination rate constant of insulin | 0 to 24 hours |
| Secondary pharmacokinetics (PK) endpoint: terminal elimination half-life (t½) | Terminal elimination half-life calculated | 0 to 24 hours |
| Secondary pharmacokinetics (PK) endpoint: time(t)50%-Insulin (INS)(early) | Time to half-maximum before Cmax | 0 to 24 hours |
| Secondary pharmacokinetics (PK) endpoint: time(t) 50%-Insulin (INS)(late) | Time to half-maximum after Cmax | 0 to 24 hours |
| Secondary pharmacodynamics (PD) endpoint: areas under the glucose infusion rate curve(AUCGIR).0-24h | Area under the glucose infusion rate curve | 0 to 24 hours |
| Secondary pharmacodynamics (PD) endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h | Area under the glucose infusion rate curve | 12 to 24 hours |
| Secondary pharmacodynamics (PD) endpoint: time to maximum glucose infusion rate(tmax.GIR) | Time to maximum glucose infusion rate | 0 to 24 hours |
| Secondary pharmacodynamics (PD) endpoint:time to half-maximum glucose infusion rate before GIRmax (tGIR.50%-early) | Time to half-maximum glucose infusion rate before GIRmax | 0 to 24 hours |
| Secondary pharmacodynamics (PD) endpoint: time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late) | Time to half-maximum glucose infusion rate after GIRmax | 0 to 24 hours |
| Secondary pharmacodynamics (PD) endpoint: Onset of action, time from trial product administration until plasma glucose concentration has decreased at least 5 mg/dL from baseline, | Time from trial product administration until plasma glucose concentration | 0 to 24 hours |
| Safety endpoint: Number of subjects with Clinically significant changes in Vital signs | Signing of Informed consent form (ICF) to follow-up period (Total duration: 44 days approximate) |
| Safety endpoint: Local tolerability assessment / Injection site reactions | Number of subjects with Injection Site Reactions | Signing of Informed consent form (ICF) to follow-up period (Total duration:44 days approximate) |
| Safety endpoint: Number of subjects with clinically significant changes in Laboratory safety parameters | Signing of Informed consent form (ICF) to follow-up period (Total duration:44 days approximate) |
| Safety endpoint: Number of subjects with clinically significant changes in ECG | Signing of Informed consent form (ICF) to follow-up period (Total duration:44 days approximate) |