Status:
COMPLETED
A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects
Lead Sponsor:
Sunshine Lake Pharma Co., Ltd.
Conditions:
Type 2 Diabetes
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 Pharmac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05294536
Start Date
June 22 2020
End Date
November 27 2020
Last Update
March 24 2022
Active Locations (1)
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1
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China, 200031