A Study Evaluating the Bioavailability of Oral Insulin (N11005)
Sponsor
Beijing Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04975022
Collaborator
(none)
12
1
2
8.1
1.5
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Research on Clinical Application of New Therapies for Diabetes and Its Complications and Related Translational Medicine Research
Actual Study Start Date
:
Dec 10, 2019
Actual Primary Completion Date
:
Aug 14, 2020
Actual Study Completion Date
:
Aug 14, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: T group
|
Drug: N11005
oral insulin N11005, 300IU, p.o.
|
| Active Comparator: R group
|
Drug: Novolin R
reference preparation Novolin R, 0.1 IU/Kg, i.h.
|
Outcome Measures
Primary Outcome Measures
- 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；]
the peak concentration
- AUC 0-8 h [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；]
the AUC for insulin from time zero to 8 hours
- AUCGIR,0-8 h [Pre-dose, 0-8 hours]
- GIRmax [Pre-dose, 0-8 hours]
Secondary Outcome Measures
- Tmax [Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300,330,360,420,480 minutes；]
time to Cmax
- AUC 0-2 h [Pre-dose, 5,10,20,30,40,50,60,75,90,105,120 minutes]
the AUC for insulin from time zero to 2 hours
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
- Volunteer to participate in the trial and sign an informed consent form; 2) 18-45 years old (including 18 and 45 years old) healthy male subjects (without heart, liver, kidney, digestive tract, neurological diseases, and metabolic abnormalities in the 4 weeks before screening; No abnormal clinically significant vital signs results, physical examination results, laboratory examination results and electrocardiogram examination results judged by the investigator at the time of screening); 3) BMI (body mass index): between 19-24 Kg/m2, including 19 and 24 Kg/m2; 4) Normal glucose tolerance (fasting plasma glucose [FPG] <6.1 mmol/L, and oral glucose tolerance test [OGTT] 2-hour postprandial blood glucose <7.8 mmol/L); 5) No family history of diabetes, obesity, etc.; 6) Insulin secretion function is normal (confirmed by insulin release test (IRT) judged by the investigator); 7) There is no planned parenthood during the study period, and it is agreed to use reliable contraceptive measures during the study period until 4 weeks after the last administration of the study drug;
- Be able to communicate well with researchers and complete research in accordance with research regulations.
Exclusion Criteria:
- 1). Those who have serious systemic diseases, infectious diseases or mental disorders; 2). The results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, syphilis test are positive; 3). Those who have used any prescription drugs, Chinese herbal medicines and/or over-the-counter drugs (except for subjects with occasional and restricted use of paracetamol) and health products (except routine vitamin supplements) within 2 weeks before screening; 4). Those who donated more than 400 mL of blood within 3 months before screening; 5). Severe smokers (25 or more cigarettes per day); 6). Alcoholics (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or those who have a positive alcohol breath test result; 7). Those who have a history of drug abuse or have a positive urine test for illegal drugs; 8). Those who are known or suspected to be allergic to insulin and/or its excipients; 9). Those who have participated in other clinical trials within 3 months before screening, or plan to participate in other clinical trials during the trial period or within 1 month after the end of the trial; 10). Those who have any food allergies or have special dietary requirements and cannot follow a unified diet; 11). Those who have undergone gastrointestinal surgery before screening, or have a history of gastric obstruction or impaired gastrointestinal motility; 12). Those who are using gastric mucosal protective agents during screening; 13). Those who are deemed unsuitable to participate in this trial after the researcher's evaluation;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Hospital | Beijing | China |
Sponsors and Collaborators
- Beijing Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Beijing Hospital
ClinicalTrials.gov Identifier:
NCT04975022
Other Study ID Numbers:
- 12013-P-01
First Posted:
Jul 23, 2021
Last Update Posted:
Jul 28, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: