- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02273518
Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers
23 de octubre de 2014 actualizado por: Boehringer Ingelheim
A Double-blind, Randomised, 3-way Cross-over Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin ER Extended Release (ER) 200 mg Dipyridamole/25 mg ASA Formulations in Healthy Male and Female Volunteers
Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
18
Fase
- Fase 1
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
21 años a 50 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- All participants in the study should be healthy males or females, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca-Index)
- Prior to admission to the study all volunteers will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent
- Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG
- Hematopoietic, hepatic and renal function tests will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations
- The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Exclusion Criteria:
- Volunteers are excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Subjects with chronic or relevant acute infections
- Subjects with allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Volunteers who have taken a drug with a long half-life (≥ 24 hours) within one month or less than ten half-lives of the respective drug before enrolment in the study
- Volunteers who receive any other drugs which might influence the results of the trial during the week previous to enrolment in the study
- Volunteers who participate in another study with an investigational drug within the last two months preceding the study
- Volunteers who are unable to refrain from smoking on study days
- Volunteers who smoke more than10 cigarettes (or equivalent) per day
- Volunteers who drink more than 60 g of alcohol per day
- Volunteers who are dependent on drugs
- Volunteers who donate blood (≥ 100 mL) within the last four weeks
- Volunteers who participate in excessive physical activities within the last week before the study (e.g. competitive sports)
- Volunteers who suffer from any other disease or abnormality of clinical relevance
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
- History of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
Female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (IUD), oral contraceptives)
- Inability to maintain this adequate contraception during the whole study period
- Lactation 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: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Asasantin ER, presente formulación comercial
|
|
|
Experimental: Asasantin ER, new formulation I
|
|
|
Experimental: Asasantin ER, new formulation II
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Area under the concentration-time curve of dipyridamole in plasma at steady state (AUC,ss)
Periodo de tiempo: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
|
Percent peak trough fluctuation of dipyridamole in plasma (%PTF)
Periodo de tiempo: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Maximum concentration of the analytes in plasma at steady state (Cmax,ss)
Periodo de tiempo: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
|
Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Periodo de tiempo: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
|
Time from dosing to the maximum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ Time from dosing to the maximum measured concentration of the analytes in plasma at steady state (tmax,ss)
Periodo de tiempo: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
|
Percent area under the curve fluctuation of the analytes in plasma (AUCfluct)
Periodo de tiempo: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
|
Terminal half-life of the analytes in plasma (t1/2)
Periodo de tiempo: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
|
Percent of dose of the analytes recovered unchanged in urine (Ae%)
Periodo de tiempo: Up to 24 hours after start of drug administration
|
Up to 24 hours after start of drug administration
|
|
Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)
Periodo de tiempo: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
|
Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate)
Periodo de tiempo: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
|
Number of subjects with clinically relevant changes in 12-lead ECG
Periodo de tiempo: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
|
Number of subjects with clinically relevant changes in laboratory values
Periodo de tiempo: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
|
Number of subjects with adverse events
Periodo de tiempo: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
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 abril de 2001
Finalización primaria (Actual)
1 de mayo de 2001
Fechas de registro del estudio
Enviado por primera vez
23 de octubre de 2014
Primero enviado que cumplió con los criterios de control de calidad
23 de octubre de 2014
Publicado por primera vez (Estimar)
24 de octubre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
24 de octubre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
23 de octubre de 2014
Última verificación
1 de octubre de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 9.144
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. .