Type 2 Diabetes Clinical Trial
Official title:
A Randomized, Open-label, Two-period, and Double-cross Comparative Study on the Pharmacokinetics of Liraglutide Injection (RD12014) and Victoza® in Healthy Volunteers
Verified date | March 2022 |
Source | Sunshine Lake Pharma Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the pharmacokinetics similarity between the liraglutide injection (RD12014) produced by Sunshine Lake Pharma Co., Ltd. and liraglutide injection (Victoza®) produced by Novo Nordisk Pharmaceutical Co., Ltd for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between RD12014 and Victoza ® in healthy subjects.
Status | Completed |
Enrollment | 50 |
Est. completion date | November 27, 2020 |
Est. primary completion date | July 20, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 1. Being willing to participate in the experiment, fully understand and sign the informed consent, fully understand and able to complete the experiment according to the requirements of the experiment protocol; - 2. Aged between 18 and 45 years old of healthy male subjects ; - 3. Weight =50kg, and body mass index(BMI)= 19.0-26.0 kg/m2 ; - 4. No history of respiratory system, cardiovascular system, digestive system, urinary system, hematological system, endocrine system,nervous system or metabolic abnormalities; - 5. Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, abdominal ultrasound examination and chest X-ray examination have no clinical significance; Exclusion Criteria: - 1. Have a history of fainting needles, fainting blood; - 2. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening; - 3. Have taken any prescription, over-the-counter, herbal medicine or health care products (other than normal vitamin products)within 2 weeks prior to the use of the study drug; - 4. Have a history of taken Liraglutide or other human glucagon-like peptides-1 analogues before the trial; - 5. Those who have been screened positive for drugs at screening; - 6. Donated blood (> 400 ml) within 3 months before taking the study drug; - 7. Heavy smoker or those who smoked more than 10 cigarettes per day before taking the study drug. - 8. Alcohol abuse (drinking 21 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of 40% alcoholic spirits or 150 ml of wine) or positive for breath alcohol test ; - 9. Those who have been screened positive for drugs or have a history of drug abuse; - 10. Known allergy to Liraglutide or any of the excipients of the formulation; - 11. Those who have a history or family history of medullary thyroid cancer (grandparents, parents and siblings), or inherited diseases that predispose them to medullary thyroid cancer;Or have a history or family history of multiple endocrine adenomatosis; - 12. Have participated in the drug clinical trial and taken the test drug within 3 months before taking the study drug; - 13. During the trial period and within 3 months after the last dose, those who want their female partners to become pregnant or is unwilling to use reliable contraceptive methods - 14. Other cases judged by researchers to be unsuitable for selection. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Xuhui Central Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Sunshine Lake Pharma 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 30mins) to 72 hours after administration | |
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 72 h | 0 hour(pre-dose,within 30mins) to 72 hours after administration | |
Secondary | Area under the plasma concentration-time curve from time zero to 8 (AUC0-8) | The area under the plasma concentration curve from 0 to 8 | 0 hour(pre-dose,within 30mins) to infinity after administration | |
Secondary | Time to reach maximum plasma concentration following drug administration (Tmax) | Time to maximum concentration | 0 hour(pre-dose,within 30mins) to 72 hours after administration | |
Secondary | Elimination half-life (t1/2) | Elimination half-life | 0 hour(pre-dose,within 30mins) to 72 hours after administration | |
Secondary | Apparent total body clearance (CL/F) | Apparent total body clearance | 0 hour(pre-dose,within 30mins) to 72 hours after administration | |
Secondary | Apparent volume of distribution (Vd/F) | Apparent volume of distribution | 0 hour(pre-dose,within 30mins) to 72 hours after administration | |
Secondary | Adverse Event, Serious Adverse Event | Monitor the safety indicators of subjects during the trial | Up to day 4 after the second dose. |
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