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Human Bioequivalence Test of Liraglutide Injection

30. August 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Studientyp

Interventionell

Einschreibung (Tatsächlich)

28

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 60 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Experimental: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Maximum (peak) plasma drug concentration(Cmax)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: up to day 15
Monitor the safety indicators of subjects during the trial
up to day 15

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
body temperature
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

21. Mai 2019

Primärer Abschluss (Tatsächlich)

1. Juni 2019

Studienabschluss (Tatsächlich)

1. Juli 2019

Studienanmeldedaten

Zuerst eingereicht

24. August 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. August 2021

Zuerst gepostet (Tatsächlich)

31. August 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. August 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. August 2021

Zuletzt verifiziert

1. August 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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