Human Bioequivalence Test of Liraglutide Injection

NCT ID: NCT05029076

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-21
• Study Completion Date: 2019-07-01

Brief 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liraglutide injection + Victoza

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

Group Type: EXPERIMENTAL

Liraglutide injection

Intervention Type: DRUG

Human glucagon-like peptides-1 analogue

Victoza

Intervention Type: DRUG

Human glucagon-like peptides-1 analogue

Victoza +Liraglutide injection

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

Group Type: EXPERIMENTAL

Liraglutide injection

Intervention Type: DRUG

Human glucagon-like peptides-1 analogue

Victoza

Intervention Type: DRUG

Human glucagon-like peptides-1 analogue

Interventions

Liraglutide injection

Human glucagon-like peptides-1 analogue

Intervention Type: DRUG

Victoza

Human glucagon-like peptides-1 analogue

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, Jilin, China

Countries

China

References

Xu Z, Liu Z, Wang Y, Xue J, Chang T, Cui Y, Cheng Y, Liu G, Wang W, Zhou Y, Yu S, Ren Q, Yang W, Qu X, Chen J, Chen X, Deng Q, Yang H, Wang X. Comparing the bioequivalence and safety of liraglutide in healthy Chinese subjects: an open, single-dose, randomized, repeated, two-sequence, two-cycle phase I clinical trial. Expert Rev Clin Pharmacol. 2023 Apr;16(4):363-370. doi: 10.1080/17512433.2023.2188192. Epub 2023 Mar 8.

Reference Type: DERIVED

PMID: 36883362 (View on PubMed)

Other Identifiers

ZDTQ-BE-2019-LLLT

Identifier Type: -

Identifier Source: org_study_id