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Human Bioequivalence Test of Liraglutide Injection

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.

Studieoversikt

Status

Fullført

Forhold

Studietype

Intervensjonell

Registrering (Faktiske)

28

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximum (peak) plasma drug concentration(Cmax)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: up to day 15
Monitor the safety indicators of subjects during the trial
up to day 15

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
body temperature
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. mai 2019

Primær fullføring (Faktiske)

1. juni 2019

Studiet fullført (Faktiske)

1. juli 2019

Datoer for studieregistrering

Først innsendt

24. august 2021

Først innsendt som oppfylte QC-kriteriene

30. august 2021

Først lagt ut (Faktiske)

31. august 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. august 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. august 2021

Sist bekreftet

1. august 2021

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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