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The objective of this study was to preliminarily verify whether the oral insulin N11005 is a prandial insulin by assessing the PK, PD, and safety profiles of N11005.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T group | Experimental |
| |
| R group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N11005 | Drug | oral insulin N11005, 300IU, p.o. |
| |
| Novolin R |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | the peak concentration | Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes; |
| AUC 0-8 h | the AUC for insulin from time zero to 8 hours | Pre-dose, 5,10,20,30,45,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes; |
| AUCGIR,0-8 h | Pre-dose, 0-8 hours | |
| GIRmax | Pre-dose, 0-8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | time to Cmax | Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300,330,360,420,480 minutes; |
| AUC 0-2 h | the AUC for insulin from time zero to 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37564986 | Derived | Pan Q, Wang X, Li W, Chen X, Zhuang Y, Zhou Q, Huang Y, Zhou Y, Lan L, Wang Z, Wang W, Hong J, Hao WH, Yang YT, Guo L. Pharmacokinetics, pharmacodynamics, and safety of prandial oral insulin (N11005) in healthy subjects. Front Endocrinol (Lausanne). 2023 Jul 26;14:1172327. doi: 10.3389/fendo.2023.1172327. eCollection 2023. |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
reference preparation Novolin R, 0.1 IU/Kg, i.h. |
|
| Pre-dose, 5,10,20,30,40,50,60,75,90,105,120 minutes |
| the elimination half-life (t1/2) of serum insulin | Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes; |
| the AUC for insulin from time zero to 4 h | Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240 minutes |
| the AUC for insulin from time zero to infinite time | Pre-dose, 5,10,20,30,45,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes; |
| AUCGIR,0-2 h | Pre-dose, 0-2 hours |
| AUCGIR,0-4 h | Pre-dose, 0-4 hours |
| tGIRmax | Pre-dose, 0-8 hours |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |