An Open-Label, Randomized, Fasting Condition, Single-dose, Cross-over Study to Evaluate the Bioequivalence "DA-5215 Tab" and "DA-5215-R Tab" in Healthy Volunteers
DA-5215 Tab
+ DA-5215-R Tab
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 2022
Fecha en la que se inscribió al primer participante.1. Study design: An open-Label, randomized, 2-sequence, 2-period, fasting condition, single-dose, per oral, cross-over study 2. Administration method: The subject should maintain a minimum of 10 hours of fasting status before administration, and give an oral dose of 1 tablet (DA-5215 or DA-5215-R) with 150 mL of water at around 8 a.m. on 1D of each period. The subject should not chew or break the drug, but should swallow in whole with water. The difference in administration time between the subjects is about one minute apart, considering the blood collection time. 3. Wash out period: at least 7 days 4. Blood collection time: Before the administration,15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 hours after the administration (total 16 times)
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 50 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 19 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
Inclusion Criteria: 1. A person who aged 19 or older at the time of screening 2. BMI of 18 to 30 (BMI calculation: kg/m2) \- Males weighing 50kg or more, Females weighing 45kg or more 3. No congenital or chronic diseases or pathological symptoms 4. A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination 5. A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP 6. A person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature Exclusion Criteria: 1. A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to the first administration of IP 2. A person who has participated in other clinical trials within six months prior to the first administration of the IP 3. A person who has had whole blood transfusion within 8 weeks or the apheresis within 2 weeks before the first administration of IP 4. A person who has medical history of gastric resection that can affect the drug absorption 5. A person with a history of regular alcohol intake within a month prior to the first administration of the IP: * Male: More than 21 cups/week * Female: More than 14 cups/week (1 cup: 50 ml of soju, 250 ml of beer, 30ml of spirits) 6. A person who is hypersensitive to any of the IP components 7. A person who has medical history of mental disease 8. A person who is judged not to be suitable for the study by the investigator 9. Lactating or possibly pregnant women
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación