A Open-label, Single Center Drug Interaction Study of Morphothiadine Mesilate/Ritonavir , Entecavir and Tenofovir Disoproxil Fumarate in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- T1/2
研究概览
简要总结
The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of Morphothiadine Mesilate/Ritonavir combined with Entecavir or Tenofovir Disoproxil Fumarate in healthy subjects
详细描述
This is a 2-part study with each part is an open-label, crossover study in healthy adult subjects.
Total 56 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 28 subjects in each part. Part A is to evaluate the drug-interaction between GLS4/RTV and ETV, Part B is to evaluate the drug-interaction between GLS4/RTV and TDF. With each part, the subject will be split into two groups and receive study drug per the defined treatment periods of Day 1, Day 11-20 and Day 21.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions
- •Be able to complete the study according to the trail protocol
- •Subjects (including partners) have no pregnancy plan within 1 year after the last dose of study drug and voluntarily take effective contraceptive measures
- •Male subjects and must be 18 to 45 years of age inclusive
- •Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg / m2, inclusive
- •Physical examination and vital signs without clinically significant abnormalities.
排除标准
- •Use of >5 cigarettes per day during the past 3 months
- •Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies)
- •History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine)
- •Donation or loss of blood over 450 mL within 3 months prior to screening
- •12-lead ECG with clinically significant
- •Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis
- •Subjects deemed unsuitable by the investigator for any other reason.
研究组 & 干预措施
Part A:Group A
Subjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21.
干预措施: GLS4 (Drug)
Part A:Group A
Subjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21.
干预措施: RTV (Drug)
Part A:Group A
Subjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21.
干预措施: ETV (Drug)
Part A:Group B
Subjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21.
干预措施: GLS4 (Drug)
Part A:Group B
Subjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21.
干预措施: RTV (Drug)
Part A:Group B
Subjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21.
干预措施: ETV (Drug)
Part B:Group C
Subjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21.
干预措施: GLS4 (Drug)
Part B:Group C
Subjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21.
干预措施: RTV (Drug)
Part B:Group C
Subjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21.
干预措施: TDF (Drug)
Part B:Group D
Subjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21.
干预措施: GLS4 (Drug)
Part B:Group D
Subjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21.
干预措施: RTV (Drug)
Part B:Group D
Subjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21.
干预措施: TDF (Drug)
结局指标
主要结局
T1/2
时间窗: Day 1-2 and Day 21-23
Terminal half-life of study drugs
AUC
时间窗: Day 1-2 and Day 21-23
Area under the plasma concentration-time curve of study drugs
Tmax
时间窗: Day 1-2 and Day 21-23
Time to maximum concentration of study drugs
Cmax
时间窗: Day 1-2 and Day 21-23
Maximum plasma concentration of study drugs
Adverse events
时间窗: Baseline to day 23
To assess the safety and tolerability after dosing
次要结局
- CL/F(Day 1-2 and Day 21-23)
- Cmin(Day 1-2 and Day 21-23)
- Vz/F(Day 1-2 and Day 21-23)