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

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Liraglutide injection,Victoza; Drug: Liraglutide injection,RD12014

Study type: Interventional

Funder types: Industry

Identifiers

NCT05294536

12014-P-01/CRC-C1944

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Liraglutide injection (RD12014)+ Victoza

Experimental group

Description:

Subjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle.

Treatment:

Drug: Liraglutide injection,RD12014

Drug: Liraglutide injection,Victoza

Victoza + Liraglutide injection (RD12014)

Experimental group

Description:

Subjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle.

Treatment:

Drug: Liraglutide injection,RD12014

Drug: Liraglutide injection,Victoza