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
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 2022
Date à laquelle le premier participant a commencé l'étude.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)
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.50 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 19 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site