- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05029076
Human Bioequivalence Test of Liraglutide Injection
30 de agosto de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
28
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Jilin
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Changchun, Jilin, Porcelana, 130021
- Affiliated Hospital of Changchun University of Traditional Chinese Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 60 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Sign the informed consent form before the trial, fully understand the trial purpose, process and possible adverse reactions;
- Able to complete the study according to the requirements of protocol;
- Aged between 18 and 60 years old, both men and women;
- Male ≥50kg, female ≥45kg,body mass index(BMI)=weight (kg)/height 2 (m2), BMI is 18-28 kg/m2 (including the critical value);
- No mental abnormalities, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system or metabolic abnormalities;
- Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance;
- 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:
- 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;
- Have a history of fainting needles, fainting blood;
- Known allergy to Liraglutide and its metabolites or any of the excipients of the formulation;
- Those who smoked more than 5 cigarettes per day during the 3 months before the trial.
- 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);
- Donated blood or lost a lot of blood (> 450 ml) within 2 months before taking the study drug ;
- 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.);
- Have taken any prescription, over-the-counter, vitamin product or herbal medicine within 1 month prior to the use of the study drug;
- 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;
- Have taken the study drug or participated in the drug clinical trial within 2 months before taking the study drug;
- Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening;
- Female subjects are breastfeeding or have a positive serum pregnancy result during the screening period or during the test;
- 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;
- Blood collection is difficult or cannot tolerate venipuncture blood collection;
- Acute illness during the screening phase or before study medication;
- The subject is unable or can not comply with ward management regulations;
- The subject is unable to complete the study due to personal reasons;
- Other cases judged by researchers to be unsuitable for selection.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Liraglutide injection + Victoza
Subjects receive liraglutide injection in the first cycle and Victoza in the second cycle.
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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.
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Human glucagon-like peptides-1 analogue
Human glucagon-like peptides-1 analogue
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Maximum (peak) plasma drug concentration(Cmax)
Periodo de tiempo: 0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
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Maximum (peak) plasma drug concentration
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0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
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Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
Periodo de tiempo: 0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
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Time to maximum concentration
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0 hour(pre-dose,within 60mins) to 72hours after administration on day1 and day 15.
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Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Periodo de tiempo: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
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The area under the plasma concentration curve from 0 to infinity
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0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
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Terminal disposition rate constant/terminal rate constant (λz)
Periodo de tiempo: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
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Apparent end elimination rate constant
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0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
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Elimination half-life (t1/2)
Periodo de tiempo: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
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The time required for the highest concentration of the drug in plasma to decrease by half
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0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
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Apparent total clearance of the drug from plasma after oral administration (CL/F)
Periodo de tiempo: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
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Apparent total body clearance
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0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
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Apparent volume of distribution after non-intravenous administration (Vd/F)
Periodo de tiempo: 0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
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Apparent volume of distribution
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0 hour(pre-dose, within 60 mins) to 72 hours after administration on day1 and day 15.
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Bioavailability (systemic availability of the administered dose)
Periodo de tiempo: 0 hour(pre-dose, within 60mins) to 72 hours after administration on day1 and day 15.
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Relative bioavailability
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0 hour(pre-dose, within 60mins) to 72 hours after administration on day1 and day 15.
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Adverse Event, Serious Adverse Event and Drug Combination
Periodo de tiempo: up to day 15
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Monitor the safety indicators of subjects during the trial
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up to day 15
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
body temperature
Periodo de tiempo: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
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abnormal body temperature
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1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
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pulse
Periodo de tiempo: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
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abnormal pulse
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1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
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blood pressure
Periodo de tiempo: 1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
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abnormal blood pressure
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1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15
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clinical symptoms
Periodo de tiempo: From the screening period to day 18 after the first administration
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Any discomfort spontaneously reported by the subject
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From the screening period to day 18 after the first administration
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The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)
Periodo de tiempo: From the screening period to day 18 after the first administration
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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
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From the screening period to day 18 after the first administration
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The Number of participants with abnormal laboratory examinations
Periodo de tiempo: From the screening period to day 18 after the first administration
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laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine
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From the screening period to day 18 after the first administration
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
21 de mayo de 2019
Finalización primaria (Actual)
1 de junio de 2019
Finalización del estudio (Actual)
1 de julio de 2019
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2021
Primero enviado que cumplió con los criterios de control de calidad
30 de agosto de 2021
Publicado por primera vez (Actual)
31 de agosto de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de agosto de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
30 de agosto de 2021
Última verificación
1 de agosto de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ZDTQ-BE-2019-LLLT
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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