Type 2 Diabetes
Conditions
Brief summary
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.
Interventions
DRUGLiraglutide injection,RD12014
single dose, s.c. injection
DRUGLiraglutide injection,Victoza
single dose, s.c. injection
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum (peak) plasma drug concentration(Cmax) | 0 hour（pre-dose,within 30mins） to 72 hours after administration | Maximum (peak) plasma drug concentration |
| Area under the plasma concentration-time curve from time zero to time t (AUC0-t) | 0 hour（pre-dose,within 30mins） to 72 hours after administration | The area under the plasma concentration curve from 0 to 72 h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Elimination half-life (t1/2) | 0 hour（pre-dose,within 30mins） to 72 hours after administration | Elimination half-life |
| Apparent total body clearance (CL/F) | 0 hour（pre-dose,within 30mins） to 72 hours after administration | Apparent total body clearance |
| Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞) | 0 hour（pre-dose,within 30mins） to infinity after administration | The area under the plasma concentration curve from 0 to ∞ |
| Adverse Event, Serious Adverse Event | Up to day 4 after the second dose. | Monitor the safety indicators of subjects during the trial |
| Apparent volume of distribution (Vd/F) | 0 hour（pre-dose,within 30mins） to 72 hours after administration | Apparent volume of distribution |
| Time to reach maximum plasma concentration following drug administration (Tmax) | 0 hour（pre-dose,within 30mins） to 72 hours after administration | Time to maximum concentration |
Countries
China
Outcome results
None listed