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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Liraglutide injection,RD12014; Drug: Liraglutide injection,Victoza

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Liraglutide injection (RD12014)+ Victoza; Subjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle.	Drug: Liraglutide injection,RD12014; single dose, s.c. injection; Drug: Liraglutide injection,Victoza; single dose, s.c. injection
EXPERIMENTAL: Victoza + Liraglutide injection (RD12014); Subjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle.	Drug: Liraglutide injection,RD12014; single dose, s.c. injection; Drug: Liraglutide injection,Victoza; single dose, s.c. injection

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 22, 2020
• Primary Completion (ACTUAL): July 20, 2020
• Study Completion (ACTUAL): November 27, 2020

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (ACTUAL): March 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: 12014-P-01/CRC-C1944

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No