Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The present study is designed to compare the pharmacokinetic, pharmacodynamic and safety characteristics of UBLIN® (test product) and NovoRapid® (reference product) in healthy male participants. The treatment consists of one single dose of the test or reference product, administered during each of the two study periods, separated by 7 days between dosing. A total of 44 participants will be enrolled in this trial and randomized in a 1:1 ratio into two groups (A/B), stratified by race (Asian, non-Asian).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UBLIN® | Experimental | Single subcutaneous administration of UBLIN® in dose 0.2 U/kg |
|
| NovoRapid® | Active Comparator | Single subcutaneous administration of NovoRapid® in dose 0.2 U/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Aspart Injection(UBLIN®) | Drug | The dosage per cycle is 0.2 U/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to the Time of Last Measurable Concentration, AUC0-t | 0 to 10 hours | |
| Peak Plasma Concentration of Insulin Aspart, Cmax | 0 to 10 hours | |
| Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From Time 0 To End Of Clamp At Time T, AUCGIR0-t | 0 to 10 hours | |
| Maximum Glucose Infusion Rate, GIRmax | 0 to 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to 2 Hours Post-Dose, AUC0-2h | 0 to 2 hours | |
| Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From 2 Hours Post-dose to the Time of Last Measurable Concentration, AUC2-t |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingtong Zhang | Contact | 15096316761 | zhangqt_0232@tul.com.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Xingtai Medical College (Xingtai Cancer Hospital) | Recruiting | Xingtai | Hebei | 054000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Two-Treatment, Two-period, Two-sequence Crossover
Not provided
Not provided
Not provided
| Insulin Aspart Injection(NovoRapid®) |
| Drug |
The dosage per cycle is 0.2 U/kg |
|
| 2 to 10 hours |
| Time to Reach Peak Plasma Concentration of Insulin Aspart, Tmax | 0 to 10 hours |
| Elimination Rate Constant, λz | 0 to 10 hours |
| Half-Life of Insulin Aspart, t1/2 | 0 to 10 hours |
| Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From Time 0 to 2 Hours Post-Dose , AUCGIR0-2h | 0 to 2 hours |
| Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From 2 Hours Post-dose To End Of Clamp At Time T, AUCGIR2-t | 2 to 10 hours |
| Time Until Maximum Glucose Infusion Rate Is Reached, TGIRmax | 0 to 10 hours |
| Time To Onset Of Action, Tonset | 0 to 10 hours |