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- Ensayo clínico NCT01777516
In Vitro Interaction Between Ticagrelor and Its Active Metabolite and Their Effects on Salicylic Acid (In_vitro_PAT)
In Vitro Study to Evaluate the Pharmacodynamic Interaction Between Ticagrelor and Its Active Metabolite (AR-C124910XX) and Their Effects on the Pharmacodynamics of Salicylic Acid : Concentration-antiplatelet Effect Relationships
This is a in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite (AR-C124910XX) and their effects on the pharmacodynamics of salicylic acid. The study consist of two parts of in-vitro study as follows;
- Part 1 : in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite.
- Part 2 : in vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite and their effect on the pharmacodynamics of salicylic acid on platelet aggregation tests with the agonist of arachidonic acid.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This is a in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite (AR-C124910XX) and their effects on the pharmacodynamics of salicylic acid. The study consist of two parts of in-vitro study as follows;
- Part 1 : in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite. Platelet aggregation tests with the agonist of adenosine diphosphate(ADP) will be assessed on the in-vitro mixtures of blank plasma and randomized paired concentrations of ticagrelor + AR-C124910XX.
- Part 2 : in vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite. Platelet aggregation tests with the agonist of arachidonic acid will be assessed on the in-vitro mixtures of blank plasma plus randomized paired concentrations of ticagrelor and AR-C124910XX and the invitro mixtures with blank plasma and ticagrelor + AR-C124910XX + salicylic acid.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Seoul, Corea, república de, 138-736
- Asan Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Subjects with body weight more than 50 kg and within 20% of the ideal body weight: ideal body weight = (height[cm] - 100)*0.9.
- Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.
Exclusion Criteria:
- Subjects who have a history or presence of any clinically significant diseases.
- Subjects who have any congenital or acquired haematological diseases.
- Subjects who had whole blood donation within the last 2 months and component blood donation within the last month.
- Subject who took any concomitant medication including non-steroidal antiinflammatory drugs(NASIDs) and vitamins currently or within 7 days prior to blood sampling.
Plan de estudios
¿Cómo está diseñado el estudio?
Cohortes e Intervenciones
Grupo / Cohorte |
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healthy volunteers
1 group with no treatment : They provide the blank plasma to be used at in vitro study.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Platelet aggregation(%) of the in vitro mixtures of blank plasma and drugs of the randomized paired concentrations
Periodo de tiempo: The tolerability of volunteers after blood sampling will be followed for the duration of hospital stay, an expected average of 5 hours.
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Plasma which were collected from healthy volunteers were used to make mixtures of drugs, ticagrelor, AR-C124910XX and salicylic acid.
ADP and arachidonic acid were used as the agonists of platelet aggregation.
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The tolerability of volunteers after blood sampling will be followed for the duration of hospital stay, an expected average of 5 hours.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Hyeong-Seok Lim, M.D., PhD, Asan Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AsanMC_CPT_PAT_2012
- A070001 (Otro número de subvención/financiamiento: Korea National Enterprise For Clinical Trials)
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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