- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07608705
A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in Healthy Participants
20 de mayo de 2026 actualizado por: Shandong Suncadia Medicine Co., Ltd.
An Open-label, Single-arm, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HRS-1301 Tablets on the Pharmacokinetics of Midazolam and Atorvastatin Calcium Tablets in Healthy Participants
This phase I study in healthy participants aims to assess the pharmacokinetics of midazolam and atorvastatin when administered alone and in combination with HRS-1301, and to assess the safety of HRS-1301 when administered alone and in combination with midazolam or atorvastatin.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
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.
Estudio Contacto
- Nombre: Ying Wang
- Número de teléfono: +86-0518-82342973
- Correo electrónico: ying.wang.yw30@hengrui.com
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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Investigador principal:
- Wei Zhao
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Contacto:
- Wei Zhao
- Número de teléfono: +86-0531-88382006
- Correo electrónico: Zhao4wei2@hotmail.com
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Contacto:
- Shuwen Yu
- Número de teléfono: +86-0531-82169349
- Correo electrónico: yaoxuebu2012@163.com
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Investigador principal:
- Shuwen Yu
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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
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Subjects must be aged ≥ 18 years and ≤ 55 years on the day of signing the informed consent form (ICF);
- At screening, body mass index (BMI) must be ≥ 19.0 kg/m² and < 28 kg/m², with body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females;
- Physical examination, vital signs, electrocardiogram (ECG), posteroanterior and lateral chest X-ray/CT, abdominal ultrasound, and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, and thyroid function) were normal or abnormal but of no clinical significance;
- Female participants must not be pregnant or lactating and must have negative pregnancy test results prior to investigational drug administration; participants must have had no unprotected sexual intercourse within two weeks prior to screening; female participants of childbearing potential and male participants with partners of childbearing potential must agree to comply with the contraception requirements for the duration specified in the protocol and have no plans to donate sperm or eggs;
- Subjects who understand the study procedures and methods, voluntarily agree to participate in this trial, and provide written informed consent (ICF).
Exclusion Criteria:
- Subjects with previous medical history or current diagnosis of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, infectious, immunological, malignant neoplastic, neurological, or psychiatric/metabolic disorders/dysfunctions, or any other disease;
- Subjects who have gastrointestinal, hepatic, renal, or other known diseases that may affect drug absorption, distribution, metabolism, or excretion, or that may reduce compliance;
- Subjects who have experienced severe trauma or undergone major surgery within 3 months prior to screening, or who plan to undergo surgery during the trial period;
- Subjects with a history of specific allergies, or with an allergic constitution, or with known hypersensitivity to any component of the investigational drug;
- Subjects who have used any medication within 2 weeks prior to screening, or who are still within 5 half-lives of any medication at the time of screening;
- Subjects who have participated in any other clinical trial of a drug or medical device within 3 months prior to screening, or who are still within 5 half-lives of a prior investigational drug at the time of screening;
- Subjects who have donated blood ≥ 200 mL or experienced significant blood loss (≥ 400 mL) within 4 weeks prior to screening, or who have received a blood transfusion within 8 weeks prior to screening;
- Subjects who have received a live (attenuated) vaccine within 4 weeks prior to screening or plan to receive such a vaccine during the trial period.
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: HRS-1301 and Midazolam or Atorvastatin Group
HRS-1301 tablets and Midazolam oral solution or Atorvastatin Calcium tablets, specified dose on specified days.
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HRS-1301 tabletas.
Atorvastatin Calcium tablets.
Midazolam oral solution.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maximum observed plasma concentration (Cmax)
Periodo de tiempo: Up to 15 days.
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Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
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Up to 15 days.
|
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Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Periodo de tiempo: Up to 15 days.
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Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
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Up to 15 days.
|
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Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Periodo de tiempo: Up to 15 days.
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Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
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Up to 15 days.
|
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Maximum observed plasma concentration (Cmax)
Periodo de tiempo: Up to 18 days.
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Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
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Up to 18 days.
|
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Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
Periodo de tiempo: Up to 18 days.
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Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
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Up to 18 days.
|
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Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Periodo de tiempo: Up to 18 days.
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Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
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Up to 18 days.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to reach maximum observed concentration (Tmax)
Periodo de tiempo: Up to 15 days.
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Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
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Up to 15 days.
|
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Terminal elimination half-life (t1/2)
Periodo de tiempo: Up to 15 days.
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Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
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Up to 15 days.
|
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Apparent clearance (CL/F)
Periodo de tiempo: Up to 15 days.
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Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
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Up to 15 days.
|
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Apparent volume of distribution (Vz/F)
Periodo de tiempo: Up to 15 days.
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Plasma pharmacokinetics (PK) parameters of Midazolam 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
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Up to 15 days.
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Maximum observed plasma concentration (Cmax)
Periodo de tiempo: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
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Up to 15 days.
|
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Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Periodo de tiempo: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Periodo de tiempo: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
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Up to 15 days.
|
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Apparent volume of distribution (Vz/F)
Periodo de tiempo: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
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Up to 18 days.
|
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Apparent clearance (CL/F)
Periodo de tiempo: Up to 18 days.
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Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
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Up to 18 days.
|
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Time to reach maximum observed concentration (Tmax)
Periodo de tiempo: Up to 18 days.
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Plasma pharmacokinetics (PK) parameters of Atorvastatin 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
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Up to 18 days.
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Terminal elimination half-life (t1/2)
Periodo de tiempo: Up to 18 days.
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Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
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Up to 18 days.
|
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Maximum observed plasma concentration (Cmax)
Periodo de tiempo: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
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Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Periodo de tiempo: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
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Up to 18 days.
|
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Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Periodo de tiempo: Up to 18 days.
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Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
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Up to 18 days.
|
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Incidence and severity of adverse events (AEs)
Periodo de tiempo: Up to 22 days.
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Safety and Tolerability.
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Up to 22 days.
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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 (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de agosto de 2026
Finalización del estudio (Estimado)
1 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
20 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de mayo de 2026
Publicado por primera vez (Actual)
27 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades metabólicas
- Dislipidemias
- Trastornos del metabolismo de los lípidos
- Enfermedades Nutricionales y Metabólicas
- Hiperlipidemias
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Ácidos grasos
- Lípidos
- Azoles
- Benzazepines
- Pirroles
- Ácidos heptanoicos
- Benzodiacepinas
- Atorvastatina
- Midazolam
Otros números de identificación del estudio
- HRS-1301-105
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
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. .
Ensayos clínicos sobre Tabletas HRS-1301
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Shandong Suncadia Medicine Co., Ltd.Terminado
-
Shandong Suncadia Medicine Co., Ltd.ReclutamientoHiperlipidemiasPorcelana
-
Shandong Suncadia Medicine Co., Ltd.Reclutamiento
-
Cingulate TherapeuticsSuspendidoTDAH | Desorden hiperactivo y deficit de atencion | Trastorno por Déficit de Atención con Hiperactividad | TDAH - Tipo combinado | Trastorno por déficit de atención con hiperactividad combinado | Déficit de Atención Hiperactividad | Hiperactividad por déficit de atenciónEstados Unidos
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Shandong Suncadia Medicine Co., Ltd.ReclutamientoCáncer de mama avanzado irresecable o metastásicoPorcelana
-
Taivex Therapeutics CorporationReclutamientoEstudio de seguridad y tolerabilidad de las cápsulas de T-1301 para tratar tumores sólidos avanzadosLinfoma | Tumor sólido avanzadoTaiwán
-
Jiangsu BioJeTay Biotechnology Co., Ltd.ReclutamientoTrombocitopenia inmune primaria (PTI)Porcelana
-
Staidson (Beijing) Biopharmaceuticals Co., LtdTerminadoTrombocitopenia inmune primariaPorcelana
-
Henan Cancer HospitalAún no reclutandoCáncer de mama avanzadoPorcelana
-
Shandong Suncadia Medicine Co., Ltd.Terminado