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Human Bioequivalence Test of Liraglutide Injection

30 augustus 2021 bijgewerkt door: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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.

Studie Overzicht

Toestand

Voltooid

Conditie

Studietype

Ingrijpend

Inschrijving (Werkelijk)

28

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Liraglutide injection + Victoza
Subjects receive liraglutide injection in the first cycle and Victoza in the second cycle.
Human glucagon-like peptides-1 analogue
Human glucagon-like peptides-1 analogue
Experimenteel: Victoza +Liraglutide injection
Subjects receive Victoza in the first cycle and liraglutide injection in the second cycle.
Human glucagon-like peptides-1 analogue
Human glucagon-like peptides-1 analogue

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximum (peak) plasma drug concentration(Cmax)
Tijdsspanne: 0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
Maximum (peak) plasma drug concentration
0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
Tijdsspanne: 0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
Time to maximum concentration
0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Tijdsspanne: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
The area under the plasma concentration curve from 0 to infinity
0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Terminal disposition rate constant/terminal rate constant (λz)
Tijdsspanne: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Apparent end elimination rate constant
0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Elimination half-life (t1/2)
Tijdsspanne: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
The time required for the highest concentration of the drug in plasma to decrease by half
0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Tijdsspanne: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Apparent total body clearance
0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Apparent volume of distribution after non-intravenous administration (Vd/F)
Tijdsspanne: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Apparent volume of distribution
0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
Bioavailability (systemic availability of the administered dose)
Tijdsspanne: 0 hour(pre-dose, within 60mins) to 72 hours after administration on day1 and day 15.
Relative bioavailability
0 hour(pre-dose, within 60mins) to 72 hours after administration on day1 and day 15.
Adverse Event, Serious Adverse Event and Drug Combination
Tijdsspanne: up to day 15
Monitor the safety indicators of subjects during the trial
up to day 15

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
body temperature
Tijdsspanne: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
abnormal body temperature
1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
pulse
Tijdsspanne: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
abnormal pulse
1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
blood pressure
Tijdsspanne: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
abnormal blood pressure
1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
clinical symptoms
Tijdsspanne: From the screening period to day 18 after the first administration
Any discomfort spontaneously reported by the subject
From the screening period to day 18 after the first administration
The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)
Tijdsspanne: From the screening period to day 18 after the first administration
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
From the screening period to day 18 after the first administration
The Number of participants with abnormal laboratory examinations
Tijdsspanne: From the screening period to day 18 after the first administration
laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine
From the screening period to day 18 after the first administration

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

21 mei 2019

Primaire voltooiing (Werkelijk)

1 juni 2019

Studie voltooiing (Werkelijk)

1 juli 2019

Studieregistratiedata

Eerst ingediend

24 augustus 2021

Eerst ingediend dat voldeed aan de QC-criteria

30 augustus 2021

Eerst geplaatst (Werkelijk)

31 augustus 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 augustus 2021

Laatste update ingediend die voldeed aan QC-criteria

30 augustus 2021

Laatst geverifieerd

1 augustus 2021

Meer informatie

Termen gerelateerd aan deze studie

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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