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CompletedNCT05029076Updated Aug 31, 2021

Human Bioequivalence Test of Liraglutide Injection

A Phase 1 interventional study of Liraglutide injection and Victoza in Type 2 Diabetes, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-31.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled May 2019, registered Aug 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

To evaluate the bioequivalence of The liraglutide injection produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Victoza® produced by Novo Nordisk (China) Pharmaceutical Co., Ltd for single dose in healthy subjects,so as to provide reference for clinical evaluation and clinical medication;To observe the safety of the test preparation liraglutide injection and the reference preparation Victoza ® in healthy subjects.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Sign the informed consent form before the trial, fully understand the trial purpose, process and possible adverse reactions;
  2. Able to complete the study according to the requirements of protocol;
  3. Aged between 18 and 60 years old, both men and women;
  4. Male ≥50kg, female ≥45kg,body mass index(BMI)=weight (kg)/height 2 (m2), BMI is 18-28 kg/m2 (including the critical value);
  5. No mental abnormalities, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system or metabolic abnormalities;
  6. Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance;
  7. The female blood pregnancy test is not pregnant, and the subjects (including male subjects) have no pregnancy plan and voluntarily take effective contraceptive measures from 2 weeks before administration to at least 3 months after the last use of the study drug. See the appendix for specific contraceptive measures.

Exclusion criteria

Exclusion Criteria:

  1. Previous disease of the neuropsychiatric system, respiratory system, cardiovascular system, digestive system, hemo-lymphatic system, liver and kidney dysfunction, endocrine system, musculoskeletal system, or other disease that the investigator determines may affect drug metabolism or safety;
  2. Have a history of fainting needles, fainting blood;
  3. Known allergy to Liraglutide and its metabolites or any of the excipients of the formulation;
  4. Those who smoked more than 5 cigarettes per day during the 3 months before the trial.
  5. History of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of 40% alcoholic spirits or 150 ml of wine);
  6. Donated blood or lost a lot of blood (> 450 ml) within 2 months before taking the study drug ;
  7. Have taken any drug that changes liver enzyme activity 28 days before taking the study drug (such as liver drug enzyme inhibitor chlorpromazine, cimetidine, ciprofloxacin, metronidazole, etc.; liver drug enzyme inducer barbital Drugs, carbamazepine, rifampicin, dexamethasone, etc.);
  8. Have taken any prescription, over-the-counter, vitamin product or herbal medicine within 1 month prior to the use of the study drug;
  9. During the trial it is necessary to use tobacco, alcohol, and caffeine-containing drinks, or certain foods that may affect metabolism (such as grapefruit, grapefruit juice, etc.), or major changes in diet or exercise habits before the test, or other effects that affect drug absorption, Factors such as distribution, metabolism, excretion, etc;
  10. Have taken the study drug or participated in the drug clinical trial within 2 months before taking the study drug;
  11. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening;
  12. Female subjects are breastfeeding or have a positive serum pregnancy result during the screening period or during the test;
  13. Those who have been screened positive for drugs or have a history of drug abuse in the past five years or have used drugs in the 3 months before the trial;
  14. Blood collection is difficult or cannot tolerate venipuncture blood collection;
  15. Acute illness during the screening phase or before study medication;
  16. The subject is unable or can not comply with ward management regulations;
  17. The subject is unable to complete the study due to personal reasons;
  18. Other cases judged by researchers to be unsuitable for selection.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Liraglutide injection + Victoza

    Subjects receive liraglutide injection in the first cycle and Victoza in the second cycle.

    Drug: Liraglutide injection · Drug: Victoza

  • Experimental
    Victoza +Liraglutide injection

    Subjects receive Victoza in the first cycle and liraglutide injection in the second cycle.

    Drug: Liraglutide injection · Drug: Victoza

Interventions

  • DrugLiraglutide injection

    Human glucagon-like peptides-1 analogue

  • DrugVictoza

    Human glucagon-like peptides-1 analogue

06

What researchers measure

Primary outcomes

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

    Maximum (peak) plasma drug concentration

    Time frame: 0 hour（pre-dose,within 60mins） to 72hours after administration on day1 and day 15.

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

    Time to maximum concentration

    Time frame: 0 hour（pre-dose,within 60mins） to 72hours after administration on day1 and day 15.

  3. 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 infinity

    Time frame: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.

  4. Terminal disposition rate constant/terminal rate constant (λz)

    Apparent end elimination rate constant

    Time frame: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.

  5. Elimination half-life (t1/2)

    The time required for the highest concentration of the drug in plasma to decrease by half

    Time frame: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.

  6. Apparent total clearance of the drug from plasma after oral administration (CL/F)

    Apparent total body clearance

    Time frame: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.

  7. Apparent volume of distribution after non-intravenous administration (Vd/F)

    Apparent volume of distribution

    Time frame: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.

  8. Bioavailability (systemic availability of the administered dose)

    Relative bioavailability

    Time frame: 0 hour（pre-dose, within 60mins） to 72 hours after administration on day1 and day 15.

  9. Adverse Event, Serious Adverse Event and Drug Combination

    Monitor the safety indicators of subjects during the trial

    Time frame: up to day 15

Secondary outcomes

  1. body temperature

    abnormal body temperature

    Time frame: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15

  2. pulse

    abnormal pulse

    Time frame: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15

  3. blood pressure

    abnormal blood pressure

    Time frame: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15

  4. clinical symptoms

    Any discomfort spontaneously reported by the subject

    Time frame: From the screening period to day 18 after the first administration

  5. The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)

    Monitor the safety indicators of subjects during the trial，For example: skin, mucous membrane, head (head, eyes, ears, nose, mouth), neck, chest (chest, breast, lung, heart), abdomen (liver, gallbladder, spleen, kidney, bladder), spine, limbs, nervous system, lymph nodes, etc，and calculate the Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: From the screening period to day 18 after the first administration

  6. The Number of participants with abnormal laboratory examinations

    laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine

    Time frame: From the screening period to day 18 after the first administration

07

Study locations

1 site
  • Affiliated Hospital of Changchun University of Traditional Chinese Medicine
    Changchun, Jilin 130021, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05029076
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Aug 31, 2021
Start date
May 21, 2019
Primary completion
Jun 1, 2019
Completion
Jul 1, 2019
Last update
Aug 31, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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