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Trial · Interventional

CompletedPhase 1Registry data

Human Bioequivalence Test of Liraglutide Injection

Overview

Status
Completed
Phase
Phase 1
Enrollment
28 participants (actual)
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
21 May 2019
Primary completion
1 Jun 2019
Completion
1 Jul 2019
First posted
31 Aug 2021
Last update posted
31 Aug 2021
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20192020
  1. Ph 1

    Human Bioequivalence Test of Liraglutide Injection

    NCT05029076

    21 May 2019 to 1 Jul 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Liraglutide injectionDrug
  • VictozaDrug

Arms2

  • Experimental

    Liraglutide injection + Victoza

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

  • Experimental

    Victoza +Liraglutide injection

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

Primary outcomes9

Outcomes the sponsor listed as primary.

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

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

    Registry description

    Maximum (peak) plasma drug concentration

  2. 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.

    Registry description

    Time to maximum concentration

  3. 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.

    Registry description

    The area under the plasma concentration curve from 0 to infinity

  4. 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.

    Registry description

    Apparent end elimination rate constant

  5. Elimination half-life (t1/2)

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

    Registry description

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

  6. 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.

    Registry description

    Apparent total body clearance

  7. 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.

    Registry description

    Apparent volume of distribution

  8. 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.

    Registry description

    Relative bioavailability

  9. Adverse Event, Serious Adverse Event and Drug Combination

    Time frame · up to day 15

    Registry description

    Monitor the safety indicators of subjects during the trial

Secondary outcomes(6)
  1. 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

    Registry description

    abnormal body temperature

  2. 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

    Registry description

    abnormal pulse

  3. 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

    Registry description

    abnormal blood pressure

  4. clinical symptoms

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

    Registry description

    Any discomfort spontaneously reported by the subject

  5. 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

    Registry description

    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

  6. The Number of participants with abnormal laboratory examinations

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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

5 results

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.

Xu et al. 2023Expert review of clinical pharmacologycited by 1

PMID 36883362DOI 10.1080/17512433.2023.2188192PUB-36883362

Full text at the publisher5 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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