- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02815787
The Drug -Drug Interaction of SP2086 and Glyburide
23 de junio de 2016 actualizado por: Jiangsu HengRui Medicine Co., Ltd.
A Single Randomized, Open, Cross-over, Phase Ie Study to Access the Drug-drug Interaction of SP2086 and Glyburide
The purpose of the study is to investigate the potential interaction between SP2086 and Glyburide after the singe and multiple oral doses treatment in healthy adult volunteers respectively.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of SP2086 and Glyburide in healthy adult volunteers.
All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences.The A sequence was that Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.The B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8; Glyburide will be administered orally (by mouth) as 200mg on Days 8.
Tipo de estudio
Intervencionista
Inscripción (Actual)
16
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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Shandong
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Jinan, Shandong, Porcelana, 250012
- Qilu Hospital of Shandong 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:
- Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2
- Had signed the informed consent himself or herself.
Exclusion Criteria:
- Have the abnormal lab or other examination results and the change have clinical significance.
- Known allergy to SP2086 or Glyburide or any of the excipients of the formulation of SP2086 or Glyburide.
- History of using the sulfa or sulfonylureas or DPP-IVor GLP-1 drugs or other similar structure drugs.
- History of severe unconsciousness hypoglycemia
- History of any surgery prior to screening in 6 months.
- History of blood donation≥400 mL prior to screening in 3 months or participate in blood donation,or by blood transfusion in one month.
- History of participate any drug or medical device prior to screening in 3 months.
- Within a month before the screening using any prescription drugs, over-the-counter drugs, Chinese herbal medicine (especially oral antidiabetics drugs) or food supplements( vitamins).
- 2 days before the randomization ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion.
- The hepatitis B surface antigen, hepatitis c antibody, HIV antibody and syphilis antibody was positive.
- Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
- Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.
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 |
---|---|
Comparador activo: SP2086 and Glyburide
The A sequence was that Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.The B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.The trial period were 25 days.
In this group,the subjects was given the drugs from A sequence to the B sequence.
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In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.
In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.
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Comparador activo: Glyburide and SP2086
The A sequence was that Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.The B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.The trial period were 25 days.In this group,the subjects was given the drugs from B sequence to the A sequence.
|
In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.
In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The maximum plasma concentration (Cmax) of SP2086
Periodo de tiempo: up to Day 25
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Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
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up to Day 25
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The maximum plasma concentration (Cmax) of SP2086 acid
Periodo de tiempo: up to Day 25
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Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
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up to Day 25
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The maximum plasma concentration (Cmax) of Glyburide
Periodo de tiempo: up to Day 25
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Cmax (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide
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up to Day 25
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The area under the plasma concentration-time curve (AUC) of SP2086
Periodo de tiempo: up to Day 25
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AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
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up to Day 25
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The area under the plasma concentration-time curve (AUC) of SP2086 acid
Periodo de tiempo: up to Day 25
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AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
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up to Day 25
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The area under the plasma concentration-time curve (AUC) of Glyburide
Periodo de tiempo: up to Day 25
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AUC (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide
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up to Day 25
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
The number of volunteers with adverse events as a measure of safety and tolerability
Periodo de tiempo: up to Day 25
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up to Day 25
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: RuiChen Guo, M.D, Qilu Hospital of Shandong University
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
1 de marzo de 2014
Finalización primaria (Actual)
1 de julio de 2014
Finalización del estudio (Actual)
1 de julio de 2014
Fechas de registro del estudio
Enviado por primera vez
3 de enero de 2016
Primero enviado que cumplió con los criterios de control de calidad
23 de junio de 2016
Publicado por primera vez (Estimar)
28 de junio de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
28 de junio de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
23 de junio de 2016
Última verificación
1 de junio de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- QLHCPI-179
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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