- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04223895
A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Adult Volunteers
Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-386 With Co-administration of D012, D326, and D337 in Healthy Adult Volunteers
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Those who are over 19 years old at the screening visit
- Those who weigh more than 50kg (45kg or more for women) at the screening visit and have a body mass index (BMI) within the range of 18-30kg/m^2
Those who meet the following conditions of blood pressure measured in a sitting position after sufficient rest at the screening visit
- Systolic blood pressure: 90mmHg or more and 139mmHg or less
- Diastolic blood pressure: 60mmHg or more and 89mmHg or less
- Those who no congenital or chronic disease based on screening and no pathological symptoms or findings in medical examination results (e.g. EEG, ECG, chest and gastroscopy or gastrointestinal radiographs, if necessary)
- The person in charge of the examination (or authorized test physician) who has determined that the test subject is suitable for the diagnostic test and electrocardiogram test such as hematology test, blood chemistry test, serology test and urine test performed according to the characteristics of the investigational drug product
- Persons agreeing to exclude the possibility of pregnancy using appropriate contraceptive methods and not providing sperm or eggs from the date of first administration of the investigational drug to the 14th day after the last administration of the investigational drug
Exclusion Criteria:
- Those who participated in other clinical trials (including bioequivalence studies) within 6 months before the first dose and received the investigational drug
- Those who used drugs that induce and inhibit metabolic enzymes, such as barbital drugs, within one month before the first dose, or who used drugs that may interfere with this test within 10 days before the first dose
- Those who have donated whole blood within 2 months before the first dose or component donation within 1 month, or have transfused within 1 month
- Those who have had a history of gastrointestinal resection that may affect the absorption of the investigational drug (except appendectomy and hernia surgery)
A person who meets the following conditions within one month before the first administration date
Excess alcohol: 21 cups / week for men and 14 cups / week for women.
[1 glass = 50 mL of shochu or 30 mL of liquor or 250 mL of beer]
- Smokers exceeding 20 cigarettes per day
Patients with the following diseases
- Patients with hypersensitivity to the main constituents or components of the investigational drug
- Severe hepatic impairment, biliary atresia or cholestasis
- Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists
- Diabetes mellitus
- Patients with moderate to severe renal impairment [glomerular filtration rate (eGFR) <60 mL / min / 1.73m^2]
- Renal vascular hypertension patients
- Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit
- Patients with myopathy or have a history of family or genetic history of myopathy
- Hypothyroidism
- If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs
- Genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
- person who is considered to be unsuitable for participation in this clinical trial for reasons other than the above selection / exclusion criteria.
- In the case of female volunteers, the suspected or lactating woman
Plan de estudios
¿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 |
|---|---|
|
Experimental: Group 1
Period 1: D012, D326, D337(3 tabs, once) / Period 2: CKD-386 F1(1 tab, once)/ Period 3: CKD-386 F2(1 tab, once)
|
A single oral dose of 1 tablet under fasting conditions for each period
Otros nombres:
A single oral dose of 1 tablet under fasting conditions for each period
Otros nombres:
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
|
|
Experimental: Group 2
Period 1: D012, D326, D337(3 tabs, once) / Period 2: CKD-386 F2(1 tab, once)/ Period 3: CKD-386 F1(1 tab, once)
|
A single oral dose of 1 tablet under fasting conditions for each period
Otros nombres:
A single oral dose of 1 tablet under fasting conditions for each period
Otros nombres:
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
|
|
Experimental: Group 3
Period 1: CKD-386 F1(1 tab, once) / Period 2: D012, D326, D337(3 tabs, once) Period 3: CKD-386 F2(1 tab, once)
|
A single oral dose of 1 tablet under fasting conditions for each period
Otros nombres:
A single oral dose of 1 tablet under fasting conditions for each period
Otros nombres:
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
|
|
Experimental: Group 4
Period 1: CKD-386 F1(1 tab, once) / Period 2: CKD-386 F2(1 tab, once) / Period 3: D012, D326, D337(3 tabs, once)
|
A single oral dose of 1 tablet under fasting conditions for each period
Otros nombres:
A single oral dose of 1 tablet under fasting conditions for each period
Otros nombres:
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
|
|
Experimental: Group 5
Period 1: CKD-386 F2(1 tab, once) / Period 2: D012, D326, D337(3 tabs, once)/ Period 3: CKD-386 F1(1 tab, once)
|
A single oral dose of 1 tablet under fasting conditions for each period
Otros nombres:
A single oral dose of 1 tablet under fasting conditions for each period
Otros nombres:
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
|
|
Experimental: Group 6
Period 1: CKD-386 F2(1 tab, once) / Period 2: CKD-386 F1(1 tab, once) / Period 3: D012, D326, D337(3 tabs, once)
|
A single oral dose of 1 tablet under fasting conditions for each period
Otros nombres:
A single oral dose of 1 tablet under fasting conditions for each period
Otros nombres:
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Periodo de tiempo: 0(predose)~72 hours
|
AUCt: Area under the concentration-time curve
|
0(predose)~72 hours
|
|
Cmax of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Periodo de tiempo: 0(predose)~72 hours
|
Cmax: Maximum plasma concentration of the drug
|
0(predose)~72 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Periodo de tiempo: 0(predose)~72 hours
|
AUCinf: Area under the concentration-time curve from zero up to ∞
|
0(predose)~72 hours
|
|
tmax each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Periodo de tiempo: 0(predose)~72 hours
|
tmax: Time to maximum plasma concentration
|
0(predose)~72 hours
|
|
AUCt/AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Periodo de tiempo: 0(predose)~72 hours
|
AUCt/AUCinf: AUCt/AUCinf Ratio
|
0(predose)~72 hours
|
|
t1/2 each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Periodo de tiempo: 0(predose)~72 hours
|
t1/2: Terminal elimination half-life
|
0(predose)~72 hours
|
|
AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D326, D337
Periodo de tiempo: 0(predose)~72 hours
|
AUCt: Area under the concentration-time curve
|
0(predose)~72 hours
|
|
Cmax of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D326, D337
Periodo de tiempo: 0(predose)~72 hours
|
Cmax: Maximum plasma concentration of the drug
|
0(predose)~72 hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: 70-4665-9174 70-4665-9174, H Plus Yangji Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- A83_04BE1917P
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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