A Single-center, Open-label Study Evaluating the Pharmacokinetics, and Safety of Multiple Dose Oral Brexpiprazole Tablets (1 mg) in Chinese Healthy Subjects

Otsuka Beijing Research Institute1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2019年4月24日最近更新: 2023年11月1日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Otsuka Beijing Research Institute
入组人数: 10
试验地点: 1
主要终点: Steady-state clearance (CLss/F)

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

This study is a single-center, open-label study evaluating the pharmacokinetics and safety of multiple dose oral administration of Brexpiprazole (1 mg) tablets in Chinese healthy subject.10 healthy adult subjects will be enrolled in this study. A single dose (Brexpiprazole 1 mg) group is set and the test drug will be administered for 14 consecutive days.

详细描述

10 healthy adult subjects will be enrolled in this study. A single dose (Brexpiprazole 1 mg) group is set and the test drug will be administered for 14 consecutive days.

After receiving the informed consent form the subject themselves, the investigators start the screening 14 days to 1 days prior to taking the study drug (D-14 to D-1).

One day before first dosing (D-1), subjects are hospitalized. On the next day (D1), after completed the hospitalization inspection, eligible subjects will be selected to start with the first dose, and from day 1 to day 14 (D1 to D14), continue once daily dosing and complete the corresponding inspection, observation and blood sampling. They continue hospitalization and are discharged on day 17 (D17) after completing the relevant examinations. On days 19, 21, 23，25 (D19, D21，D23 and D25), blood samples are collected and safety evaluation is performed.

Telephone follow-up is performed on day 44 (D44, 30 days after the last dose of the drug).

Subjects who early terminated the test after taking the study drug should be tested at the end of the study (D25/ET) as far as possible.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Sign the informed consent form
•At the age of 18~45 years old (including upper and lower limits).
•Body weight of not less than 45 kg, body mass index 19 ~ 25kg/m2 range (including the upper and lower limits) [ body mass index (BMI) = body weight (kg) / height2 (m2)].

排除标准

•Participated in any drug test within 12 weeks prior to enrollment.
•Drug abuse in the past 2 years or a history of substance abuse.
•Drinking alcohol more than 2 unit per day (1 unit= 360 ml beer , or 45 ml 4.0% alcohol, or 150 ml liquor, or 50 ml wine ) 6 months before the screening, or subjects can not stop drinking during the hospitalization.
•Drug abuse urine test at screening is positive.
•Other protocol-defined inclusion and exclusion criteria may apply.

研究组 & 干预措施

Multiple dose oral administration

Experimental

1mg Once Daily (QD) , oral administration,14 consecutive days

干预措施: Brexpiprazole (Drug)