A Open-Label, Randomized, 2-sequence, 2-period, Fasted Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence of "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg) and "Twolion Tab" (Bepotastine Besilate 10mg) in Healthy Volunteers

Dong-A ST Co., Ltd.1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2019年4月23日最近更新: 2020年2月10日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Dong-A ST Co., Ltd.
入组人数: 32
试验地点: 1
主要终点: Peak Plasma Concentration(Cmax) of Bepotastine Besilate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

An Open-Label, Randomized, 2-sequence, 2-period, Fasted Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence of "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg) and "Twolion Tab" (Bepotastine Besilate 10mg) in Healthy Volunteers

详细描述

Study design: An open-Label, randomized, 2-sequence, 2-period, fasted condition, single-dose, per oral, cross-over study
Administration method:

The subject should maintain a minimum of 10 hours of empty stomach before administration, and give an oral dose of 1 tablets (Bepotastine Besilate 10 mg) with 150 mL of water at around 8 a.m. on the day of the test at room temperature. The test subject should not chew the drug or break it, but should swallow in whole with water. The difference in administration time between the test subjects is about one minute apart, considering the collection time. 3. Wash out period: 7 days 4. Blood collection time: Before the administration, 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 3, 4, 6, 8, 12 hr after the administration (total 13 times) 5. Analysis: Measurement of the concentration of an unchangeable substance of Bepotastine in plasma

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 19 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•A person who aged 19 or older at the time of screening
•No congenital or chronic diseases or pathological symptoms on screening
•A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
•BMI of 18 to 30 (BMI calculation: kg/m2)
•No history of gastrointestinal resection that may affect the absorption of drugs
•No medical history of mental illness within five years prior to screening
•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
•A person who is willing and able to follow all scheduled hospitalization and outpatient visits, medications, clinical laboratory examination and the terms of compliance
•Female patients who were confirmed to be not pregnant at medical examination

排除标准

•A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to screening
•A person who uses drugs that can affect the study within 10 days before screening
•A person who is considered unsuitable to participate in the study by the investigator
•A person who has participated in other clinical trials within three months prior to the first administration of the IP
•A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before screening
•A person who is hypersensitive to venipuncture
•A person with a history of regular alcohol intake within six months prior to screening:
•Women: More than 14 cups/week
•Men: More than 21 glasses/week (1 shot: 50 ml of soju, 30 ml of spirits, 250 ml of beer)
•Hypersensitive to any of the IP components
•Blood AST (GOT) or ALT (GPT) levels exceed the upper reference range limit by 2 times or γ-GTP levels exceed the upper reference range limit by 1.5 times
•Lactating women
•A person who does not agree to exclude the possibility of pregnancy using the contraception from the date of the first administration of the IP until the 7th day after the last administration.