A Open Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Safety of Duloxetine in Chinese Han Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pharmacokinetics as evaluated from blood concentrations of duloxetine
研究概览
简要总结
The primary objective of this study is to evaluate the pharmacokinetics of duloxetine hydrochloride tablets in Chinese Han Healthy Subjects. The single oral dose and multiple oral dose of the drug in the body and the effects of different dosages of the drug will also be evaluated.
详细描述
This is an open, parallel assignment (low-dose, moderate-dose and high-dose), inpatient, sequential-group pharmacokinetics study of single oral administered and multiple oral administered to healthy Chinese male and female subjects at a single investigational site. All subjects are from the Chinese Han race.
Approximately 36 healthy male and female Chinese subjects will participate in this study. One half of the subjects enrolled in each dose group will be female. Twelve subjects will be enrolled in each of 3 dose level groups.
Safety will be evaluated from self-reported adverse events, scheduled physical examination, vital signs, 12-lead ECGs, and clinical laboratory test results.
Single-dose blood samples (5 mL) will be obtained within 2 hours before test article administration and at 1, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours after test article administration.
Multiple-dose (subjects of moderate dose group finished first step single-dose 30mg trial, one week later, will be repeatedly administered duloxetine 30 mg 7days) blood samples (5 mL) will be obtained at 4th, 5th, 6th and 7th day before test article administration (to test the valley concentration)and at 1, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours after last test article administration (7th day).
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
- •Healthy Chinese Han male or female determined by the investigator on the basis of medical history and physical examination
- •Age from 18 to 45 years old at screening
- •Body mass index (BMI) from 19~24 kg/m2 and body weight ≥ 50 kg at screening
- •Normal clinical laboratory test results or 'no clinical significantly abnormal' results judged by the investigator at screening
- •Subjects can comply with all requirements of the study according to study procedure
- •A sighed and dated ICF (informed consent form) with approval by IEC
排除标准
- •Participation in any drug trial within 1 month prior to enrollment into this study
- •Known hypersensitivity to duloxetine hydrochloride or relative compounds
- •Abnormal 12-lead electrocardiogram (ECG) results and increasing risk to participate this study determined by investigator
- •Presence or history of any medical disorder, including cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, psychiatric and neurologic system, or medical conditions that would significantly affect the absorption, distribution, metabolism, or excretion of investigational drug, or increase risk to administer investigational drug, or interfere explanation for data
- •History of hepatitis B and/or HBsAg (+)
- •Serum HIV antibody (+) or hepatitis C Antibody (+)
- •Female subjects of childbearing potential with a positive human chorionic gonadotropin (HCG) test or lack of a reliable method of contraception
- •History of blood donor within 3 months prior to enrollment
- •History of drug abuse or alcoholism
- •Use any drugs including traditional Chinese Medicine within 1 week prior to enrollment
- •Any unsuitable subjects judged by the investigator
研究组 & 干预措施
low dose group
single oral administer 15mg duloxetine
干预措施: duloxetine (Drug)
moderate dose group/multiple dose group
single oral duloxetine 30mg, after that repeat 7 oral duloxetine 30mg/d
干预措施: duloxetine (Drug)
high dose group/crossover group
single oral duloxetine 60mg, after that single oral innovator duloxetine 60mg
干预措施: duloxetine (Drug)
结局指标
主要结局
Pharmacokinetics as evaluated from blood concentrations of duloxetine
时间窗: 2 months
次要结局
- Safety and tolerability as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, cardiac rhythm monitoring, 12 lead ECG and clinical laboratory results(2 months)
- Serum BDNF level as evaluated from blood sample(2 months)