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

• Status: Completed
• Trial end date: 2020-11-27
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.
• Treatments: Liraglutide

Criteria

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.