A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-label, Two-period, and Double-cross Comparative Study on the Pharmacokinetics of Liraglutide Injection (RD12014) and Victoza® in Healthy Volunteers

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Liraglutide injection,RD12014
* Drug: Liraglutide injection,Victoza


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide injection (RD12014)+ Victoza<br>Subjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle. | Drug: Liraglutide injection,RD12014<br>* single dose, s.c. injection<br>Drug: Liraglutide injection,Victoza<br>* single dose, s.c. injection<br>|
| Experimental: Victoza + Liraglutide injection (RD12014)<br>Subjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle. | Drug: Liraglutide injection,RD12014<br>* single dose, s.c. injection<br>Drug: Liraglutide injection,Victoza<br>* single dose, s.c. injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum (peak) plasma drug concentration(Cmax) | Maximum (peak) plasma drug concentration | 0 hour（pre-dose,within 30mins） to 72 hours after administration | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞) | The area under the plasma concentration curve from 0 to ∞ | 0 hour（pre-dose,within 30mins） to infinity after administration | 
| 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 | 
| Elimination half-life (t1/2) | Elimination half-life | 0 hour（pre-dose,within 30mins） to 72 hours after administration | 
| Apparent total body clearance (CL/F) | Apparent total body clearance | 0 hour（pre-dose,within 30mins） to 72 hours after administration | 
| Apparent volume of distribution (Vd/F) | Apparent volume of distribution | 0 hour（pre-dose,within 30mins） to 72 hours after administration | 
| Adverse Event, Serious Adverse Event | Monitor the safety indicators of subjects during the trial | Up to day 4 after the second dose. |