- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04667156
Study to Investigate Relative Bioavailability of Different Formulations of SHR6390 in Healthy Subjects
11 de octubre de 2021 actualizado por: Jiangsu HengRui Medicine Co., Ltd.
A Single-centre, Single Dose, Randomized, Open-label, Three Period, Six Sequence, Cross Controlled Study to Assess the Relative Bioavailability of the New and Traditional Formulations on SHR6390 in Healthy Subjects
The purpose of this study is to investigate relative bioavailability during the new and traditional formulations of SHR6390 in healthy subjects
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
24
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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Hubei
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Wuhan, Hubei, Porcelana, 470071
- Zhongnan Hospital of Wuhan University
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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 45 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Execute an informed consent;
- Male or female aged 18-45 years (including threshold) on the date of signing the informed consent;
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) in the range of 19.0-26.0 kg / m2 (including the critical value);
- Physical examination, vital signs, laboratory examination , 12-Lead ECG, abdominal B-ultrasound, chest X-ray, etc. are normal or abnormal, but the researcher has no clinical significance according to NCI CTCAE 5.0 standard;
- Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 7 months from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women within 72 hours before the first administration of the study drug should be negative.
Exclusion Criteria:
- Those who have previously suffered from primary diseases of important organs, including but not limited to neuropsychiatric, cardiovascular, digestive tract, respiratory system, urinary, endocrine, blood, immune and other diseases, which are judged by the researchers to be unsuitable for the trial;
- Patients who have received any previous operation affecting gastrointestinal absorption;
- Patients who had received any surgery within 6 months before screening, or planned to undergo surgery during the study period;
- Those who lost blood or donated more than 400 ml or received blood transfusion within 3 months before screening;
- HBsAg positive, HCV antibody positive, HIV antibody positive, syphilis antibody positive;
- History of drug use or drug abuse, or drug screening positive;
- Smoking and alcohol addict and unable to stop smoking during the test period; those with positive alcohol screening; those with positive nicotine screening;
- Allergic constitution, including severe drug allergy or drug allergy history; known allergy to shr6390 tablets or its excipients;
- Having swallowing resistance or disorder, affecting drug absorption;
- Participated in other clinical trials and taken the study drug within 3 months before taking the study drug for the first time;
- Inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C8 were taken within 4 weeks before the first administration of study drug;
- Taking any prescription drug, over-the-counter drug, traditional Chinese medicine or food supplement within 2 weeks before taking the study drug for the first time;
- Ingestion of grapefruit containing products, fruit juice, food or beverage containing methylxanthine or alcohol within 72 hours before taking the study drug for the first time; taking strenuous exercise; or having other factors affecting the absorption, distribution, metabolism and excretion of drugs;
- Lactating women;
- The researchers considered that the subjects had any other factors that were not suitable for the trial.
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Sequence 1
Intervention: Drug: SHR6390 new formulation 1(T1) in the first period; SHR6390 new formulation 2 (T2) in the second period; SHR6390 traditional formulation (R) in the last period
|
SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
|
|
Experimental: Sequence 2
Intervention: Drug: SHR6390 traditional formulation (R) in the first period; SHR6390 new formulation 1 (T1) in the second period; SHR6390 new formulation 2 (T2) in the last period
|
SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
|
|
Experimental: Sequence 3
Intervention: Drug: SHR6390 new formulation 2(T2) in the first period; SHR6390 traditional formulation (R) in the second period; SHR6390 new formulation 1 (T1) in the last period
|
SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
|
|
Experimental: Sequence 4
Intervention: Drug: SHR6390 new formulation 1(T1) in the first period; SHR6390 traditional formulation (R) in the second period; SHR6390 new formulation 2 (T2) in the last period
|
SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
|
|
Experimental: Sequence 5
Intervention: Drug: SHR6390 new formulation 2(T2) in the first period; SHR6390 new formulation 1 (T1) in the second period; SHR6390 traditional formulation (R) in the last period
|
SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
|
|
Experimental: Sequence 6
Intervention: Drug: SHR6390 traditional formulation (R) in the first period; SHR6390 new formulation 2 (T2) in the second period; SHR6390 new formulation 1 (T1) in the last period
|
SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fr
Periodo de tiempo: Day1~Day35
|
Relative bioavailability of the two new formulations on SHR6390
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Day1~Day35
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|
Cmax
Periodo de tiempo: Day1~Day35
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Maximum concentration of SHR6390
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Day1~Day35
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|
AUC0-t
Periodo de tiempo: Day1~Day35
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Area under the concentration-time curve from time zero to time t of SHR6390
|
Day1~Day35
|
|
AUC0-∞
Periodo de tiempo: Day1~Day35
|
Area under the concentration-time curve extrapolated to infinity of SHR6390
|
Day1~Day35
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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)
13 de diciembre de 2020
Finalización primaria (Actual)
29 de enero de 2021
Finalización del estudio (Actual)
29 de enero de 2021
Fechas de registro del estudio
Enviado por primera vez
2 de diciembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
9 de diciembre de 2020
Publicado por primera vez (Actual)
14 de diciembre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de octubre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
11 de octubre de 2021
Última verificación
1 de octubre de 2021
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- SHR6390-I-112
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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
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