Skip to main content
OpenTrials
Completed

NCT Number: NCT05294536

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liraglutide injection,RD12014

Drug

single dose, s.c. injection

Liraglutide injection,Victoza

Drug

single dose, s.c. injection

Primary outcomes

  1. Maximum (peak) plasma drug concentration(Cmax)

    Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration

    Maximum (peak) plasma drug concentration

  2. Area under the plasma concentration-time curve from time zero to time t (AUC0-t)

    Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration

    The area under the plasma concentration curve from 0 to 72 h

Secondary outcomes

  1. Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞)

    Time frame: 0 hour(pre-dose,within 30mins) to infinity after administration

    The area under the plasma concentration curve from 0 to ∞

  2. Time to reach maximum plasma concentration following drug administration (Tmax)

    Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration

    Time to maximum concentration

  3. Elimination half-life (t1/2)

    Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration

    Elimination half-life

  4. Apparent total body clearance (CL/F)

    Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration

    Apparent total body clearance

  5. Apparent volume of distribution (Vd/F)

    Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration

    Apparent volume of distribution

  6. Adverse Event, Serious Adverse Event

    Time frame: Up to day 4 after the second dose.

    Monitor the safety indicators of subjects during the trial

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2022
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.