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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05294536
• Other study ID #: 12014-P-01/CRC-C1944
• Status: Completed
• Phase: Phase 1
• Start date: June 22, 2020
• Est. completion date: November 27, 2020

Study information

• Verified date: March 2022
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 27, 2020
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Liraglutide injection,RD12014
single dose, s.c. injection
• Liraglutide injection,Victoza
single dose, s.c. injection

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum (peak) plasma drug concentration(Cmax)	Maximum (peak) plasma drug concentration	0 hour(pre-dose,within 30mins) to 72 hours after administration
Primary	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	Area under the plasma concentration-time curve from time zero to 8 (AUC0-8)	The area under the plasma concentration curve from 0 to 8	0 hour(pre-dose,within 30mins) to infinity after administration
Secondary	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
Secondary	Elimination half-life (t1/2)	Elimination half-life	0 hour(pre-dose,within 30mins) to 72 hours after administration
Secondary	Apparent total body clearance (CL/F)	Apparent total body clearance	0 hour(pre-dose,within 30mins) to 72 hours after administration
Secondary	Apparent volume of distribution (Vd/F)	Apparent volume of distribution	0 hour(pre-dose,within 30mins) to 72 hours after administration
Secondary	Adverse Event, Serious Adverse Event	Monitor the safety indicators of subjects during the trial	Up to day 4 after the second dose.