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

Sponsor
Sunshine Lake Pharma Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05294536
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
5.2
Actual Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Liraglutide injection,RD12014
  • Drug: Liraglutide injection,Victoza
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 22, 2020
Actual Primary Completion Date :
Jul 20, 2020
Actual Study Completion Date :
Nov 27, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Maximum (peak) plasma drug concentration(Cmax) [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) [0 hour（pre-dose,within 30mins） to 72 hours after administration]

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

Secondary Outcome Measures

  1. Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞) [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) [0 hour（pre-dose,within 30mins） to 72 hours after administration]

    Time to maximum concentration

  3. Elimination half-life (t1/2) [0 hour（pre-dose,within 30mins） to 72 hours after administration]

    Elimination half-life

  4. Apparent total body clearance (CL/F) [0 hour（pre-dose,within 30mins） to 72 hours after administration]

    Apparent total body clearance

  5. Apparent volume of distribution (Vd/F) [0 hour（pre-dose,within 30mins） to 72 hours after administration]

    Apparent volume of distribution

  6. Adverse Event, Serious Adverse Event [Up to day 4 after the second dose.]

    Monitor the safety indicators of subjects during the trial

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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;
    1. Aged between 18 and 45 years old of healthy male subjects ;
    1. Weight ≥50kg, and body mass index(BMI)= 19.0-26.0 kg/m2 ;
    1. No history of respiratory system, cardiovascular system, digestive system, urinary system, hematological system, endocrine system,nervous system or metabolic abnormalities;
    1. 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;
    1. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening;
    1. 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;
    1. Have a history of taken Liraglutide or other human glucagon-like peptides-1 analogues before the trial;
    1. Those who have been screened positive for drugs at screening;
    1. Donated blood (> 400 ml) within 3 months before taking the study drug;
    1. Heavy smoker or those who smoked more than 10 cigarettes per day before taking the study drug.
    1. 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 ;
    1. Those who have been screened positive for drugs or have a history of drug abuse;
    1. Known allergy to Liraglutide or any of the excipients of the formulation;
    1. 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;
    1. Have participated in the drug clinical trial and taken the test drug within 3 months before taking the study drug;
    1. 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
    1. Other cases judged by researchers to be unsuitable for selection.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Xuhui Central Hospital Shanghai Shanghai China 200031

Sponsors and Collaborators

  • Sunshine Lake Pharma Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunshine Lake Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05294536
Other Study ID Numbers:
  • 12014-P-01/CRC-C1944
First Posted:
Mar 24, 2022
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liraglutide

Study Results

No Results Posted as of Mar 24, 2022