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Human Bioequivalence Test of Liraglutide Injection
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
28
actual
Study population
Healthy volunteers
Key I/E criterion
•BMI 18-28
Primary endpoints
•Maximum (peak) plasma drug concentration(Cmax)•Reach maximum (peak) plasma concentration following drug administration (Tmax)•AUC
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (15)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Cardiometabolic biomarkers
2 endpointspulse
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
Heart rate, change
change from baseline, improvement
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
descriptive
Safety / tolerability / PK
13 endpointsMaximum (peak) plasma drug concentration(Cmax)
Time frame:0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
Cmax
concentration, descriptive
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
Time frame:0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
Tmax
descriptive
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Time frame:0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
AUC₀–∞
concentration, descriptive
Terminal disposition rate constant/terminal rate constant (λz)
Time frame:0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
descriptive
Elimination half-life (t1/2)
Time frame:0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Half-life
descriptive
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Time frame:0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
descriptive
Apparent volume of distribution after non-intravenous administration (Vd/F)
Time frame:0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
descriptive
Bioavailability (systemic availability of the administered dose)
Time frame:0 hour(pre-dose, within 60mins) to 72 hours after administration on day1 and day 15.
descriptive
Adverse Event, Serious Adverse Event and Drug Combination
Time frame:up to day 15
descriptive
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
descriptive
clinical symptoms
Time frame:From the screening period to day 18 after the first administration
descriptive
The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)
Time frame:From the screening period to day 18 after the first administration
Treatment-emergent AEs (any)
event count, event
The Number of participants with abnormal laboratory examinations
Time frame:From the screening period to day 18 after the first administration
descriptive, event
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Expert review of clinical pharmacology2023 Apr (month)PMID36883362doi:10.1080/17512433.2023.2188192via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.