- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01071720
The Effect of Food on the Pharmacokinetic Characteristics of CKD-501 (CKD-501 FDI)
Clinical Study to Assess the Effect of Food on the Pharmacokinetic Characteristics of CKD-501 in Healthy Subjects
The purpose of this study is to assess the effect of food on the pharmacokinetic characteristics of CKD-501 in healthy subject.
And, secondarily, pharmacokinetic characteristics of the main metabolites will be identified.
Descripción general del estudio
Descripción detallada
Healthy volunteers are administrated single-dose (CKD-501 1mg), two treatment(fed vs. fasting), two-period, two sequence crossover.
Every time before and after each medication, PK parameters and safety of CKD-501 1mg is performed using a blood sample and conducting some tests respectively.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Between 20 aged and 45 aged in healthy adults
- Weight more than 45kg, IBW 20% within the range
- Agreement with written informed consent
Exclusion Criteria:
- Subject has symptoms of acute disease within 28 days of starting administration of investigational drug
- Subject with known for history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases and so on) with affect the ADME of drug
- Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy disease
- Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
Inadequate result of laboratory test
- AST(SGOT) or ALT(SGPT) > 1.25 x upper limit of normal range
- Total bilirubin > 1.5 x upper limit of normal range
- Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
- Subject with known for hypersensitivity reactions to glitazone
- Previously participated in other trial within 60 days
- Treatment with dug-medicated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
- Subject takes an abnormal meal which affect the ADME of drug
- Not able to taking the institutional standard meal
- Previously make whole blood donation within 60 days or component blood donation within 20 days
- Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette > 10 cigarettes per day)
- An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
- Subject who not practice contraception during clinical trial or pregnant women(including positive pregnancy test) or nursing mothers
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: CKD-501 1mg (fed-fasted group)
CKD-501 1mg should be administered following a high-fat, high-caloric diet(fed condition) in one period and on an empty stomach(fasting condition) in the other period.
|
This study is randomized, balanced, single-dose, two treatment (fed versus fasting), two-period, two sequence crossover design to assess the effects of food on pharmacokinetics profile.
|
Otro: CKD-501 1mg (fasted-fed group)
CKD-501 1mg should be administered on an empty stomach(fasting condition) in one period and following a high-fat, high-caloric diet(fed condition) in the other period.
|
This study is randomized, balanced, single-dose, two treatment (fed versus fasting), two-period, two sequence crossover design to assess the effects of food on pharmacokinetics profile.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
To evaluate the pharmacokinetics of CKD-501 1mg (fed vs. fasting)
Periodo de tiempo: 0-48 hrs
|
0-48 hrs
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
To evaluate the safety of CKD-501 1mg from vital signs, physical exam, ECG, laboratory test, adverse event and so on
Periodo de tiempo: Throughout the trial
|
Throughout the trial
|
Colaboradores e Investigadores
Patrocinador
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
Palabras clave
Otros números de identificación del estudio
- CKD-19HPS09L
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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