Type 2 Diabetes Clinical Trial
Official title:
Human Bioequivalence Test of Liraglutide Injection
Verified date | August 2021 |
Source | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the bioequivalence of The liraglutide injection produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Victoza® produced by Novo Nordisk (China) Pharmaceutical Co., Ltd for single dose in healthy subjects,so as to provide reference for clinical evaluation and clinical medication;To observe the safety of the test preparation liraglutide injection and the reference preparation Victoza ® in healthy subjects.
Status | Completed |
Enrollment | 28 |
Est. completion date | July 1, 2019 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Sign the informed consent form before the trial, fully understand the trial purpose, process and possible adverse reactions; 2. Able to complete the study according to the requirements of protocol; 3. Aged between 18 and 60 years old, both men and women; 4. Male =50kg, female =45kg,body mass index(BMI)=weight (kg)/height 2 (m2), BMI is 18-28 kg/m2 (including the critical value); 5. No mental abnormalities, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system or metabolic abnormalities; 6. Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance; 7. The female blood pregnancy test is not pregnant, and the subjects (including male subjects) have no pregnancy plan and voluntarily take effective contraceptive measures from 2 weeks before administration to at least 3 months after the last use of the study drug. See the appendix for specific contraceptive measures. Exclusion Criteria: 1. Previous disease of the neuropsychiatric system, respiratory system, cardiovascular system, digestive system, hemo-lymphatic system, liver and kidney dysfunction, endocrine system, musculoskeletal system, or other disease that the investigator determines may affect drug metabolism or safety; 2. Have a history of fainting needles, fainting blood; 3. Known allergy to Liraglutide and its metabolites or any of the excipients of the formulation; 4. Those who smoked more than 5 cigarettes per day during the 3 months before the trial. 5. History of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of 40% alcoholic spirits or 150 ml of wine); 6. Donated blood or lost a lot of blood (> 450 ml) within 2 months before taking the study drug ; 7. Have taken any drug that changes liver enzyme activity 28 days before taking the study drug (such as liver drug enzyme inhibitor chlorpromazine, cimetidine, ciprofloxacin, metronidazole, etc.; liver drug enzyme inducer barbital Drugs, carbamazepine, rifampicin, dexamethasone, etc.); 8. Have taken any prescription, over-the-counter, vitamin product or herbal medicine within 1 month prior to the use of the study drug; 9. During the trial it is necessary to use tobacco, alcohol, and caffeine-containing drinks, or certain foods that may affect metabolism (such as grapefruit, grapefruit juice, etc.), or major changes in diet or exercise habits before the test, or other effects that affect drug absorption, Factors such as distribution, metabolism, excretion, etc; 10. Have taken the study drug or participated in the drug clinical trial within 2 months before taking the study drug; 11. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening; 12. Female subjects are breastfeeding or have a positive serum pregnancy result during the screening period or during the test; 13. Those who have been screened positive for drugs or have a history of drug abuse in the past five years or have used drugs in the 3 months before the trial; 14. Blood collection is difficult or cannot tolerate venipuncture blood collection; 15. Acute illness during the screening phase or before study medication; 16. The subject is unable or can not comply with ward management regulations; 17. The subject is unable to complete the study due to personal reasons; 18. Other cases judged by researchers to be unsuitable for selection. |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Changchun University of Traditional Chinese Medicine | Changchun | Jilin |
Lead Sponsor | Collaborator |
---|---|
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum (peak) plasma drug concentration(Cmax) | Maximum (peak) plasma drug concentration | 0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15. | |
Primary | Time to reach maximum (peak) plasma concentration following drug administration (Tmax) | Time to maximum concentration | 0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15. | |
Primary | Area under the plasma concentration-time curve from time zero to time t (AUC0-t) | The area under the plasma concentration curve from 0 to infinity | 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15. | |
Primary | Terminal disposition rate constant/terminal rate constant (?z) | Apparent end elimination rate constant | 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15. | |
Primary | Elimination half-life (t1/2) | The time required for the highest concentration of the drug in plasma to decrease by half | 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15. | |
Primary | Apparent total clearance of the drug from plasma after oral administration (CL/F) | Apparent total body clearance | 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15. | |
Primary | Apparent volume of distribution after non-intravenous administration (Vd/F) | Apparent volume of distribution | 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15. | |
Primary | Bioavailability (systemic availability of the administered dose) | Relative bioavailability | 0 hour(pre-dose, within 60mins) to 72 hours after administration on day1 and day 15. | |
Primary | Adverse Event, Serious Adverse Event and Drug Combination | Monitor the safety indicators of subjects during the trial | up to day 15 | |
Secondary | body temperature | abnormal body temperature | 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15 | |
Secondary | pulse | abnormal pulse | 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15 | |
Secondary | blood pressure | abnormal blood pressure | 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15 | |
Secondary | clinical symptoms | Any discomfort spontaneously reported by the subject | From the screening period to day 18 after the first administration | |
Secondary | The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination) | Monitor the safety indicators of subjects during the trial,For example: skin, mucous membrane, head (head, eyes, ears, nose, mouth), neck, chest (chest, breast, lung, heart), abdomen (liver, gallbladder, spleen, kidney, bladder), spine, limbs, nervous system, lymph nodes, etc,and calculate the Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | From the screening period to day 18 after the first administration | |
Secondary | The Number of participants with abnormal laboratory examinations | laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine | From the screening period to day 18 after the first administration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05219994 -
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
|
N/A | |
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Completed |
NCT02284893 -
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
|
Phase 3 | |
Completed |
NCT04274660 -
Evaluation of Diabetes and WELLbeing Programme
|
N/A | |
Active, not recruiting |
NCT05887817 -
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
|
Phase 4 | |
Active, not recruiting |
NCT05566847 -
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Completed |
NCT04965506 -
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
|
Phase 2 | |
Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
Active, not recruiting |
NCT03982381 -
SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
Completed |
NCT04496154 -
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
|
N/A | |
Completed |
NCT04023539 -
Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05530356 -
Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
|
||
Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
Completed |
NCT04097600 -
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets
|
Phase 1 | |
Completed |
NCT05378282 -
Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
|
||
Recruiting |
NCT06010004 -
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT03653091 -
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
|
N/A |