A Phase 1 Clinical Trial to Evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety in Healthy Chinese Adults After Multiple Intravenous Administration of Dexlansoprazole
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percentage time with the intragastric potential of hydrogen (pH)>4
研究概览
简要总结
This is a single center, open-label, multiple-dose phase 1 clinical trial. This study will determine the pharmacokinetics (PK), pharmacodynamics (PD), safety and side-effect profile of an investigational dexlansoprazole injection after multiple intravenous administration in healthy Chinese adults.
详细描述
This is a single center, open-label, multiple-dose clinical trial. 5 dosing groups were designed, including 15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days, and 30 mg q12h in an active comparator, lansoprazole, treatment arm for 5 days. The study will enroll approximately 70 participants with 14 cases in each group. Participants will make 3 visits to the clinic including 8-day of confinement to the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 Years;
- •Male (weight ≥50kg) or female (weight ≥45kg);
- •Body mass index (BMI) between 19~28 kg/m2;
- •In good health as determined by a physician/investigator based on medical history, vital signs, electrocardiogram (ECG), laboratory tests and physical examination findings at screening;
- •Subject who totally understand the aim and progress of this clinical trial, make decision by his/her free will, and signed a consent form to follow the progress;
- •Female participant of childbearing potential must have a negative serum pregnancy test at screening, and agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 6 months following the last dose of study drug;
- •Male participant agrees to use adequate contraception and have no plan to donate sperm from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;
- •In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
排除标准
- •Positive breath test result for H pylori at Screening;
- •Cannot tolerate placement of the pH probe;
- •Has poor peripheral venous access;
- •Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator;
- •Subject who has past or present history of any serious diseases, including (but not limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, psychiatric or neurological, hematologic, immunological or metabolic disorders;
- •Human immunodeficiency virus(HIV), hepatitis B virus(HBV), or syphilis positive;
- •Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as alcohol consumption exceeding 14 units per week) within 6 months preceding this study or is unwilling to agree to abstain from alcohol and drugs throughout the study;
- •Heavy smokers (>5 cigarettes per day) within 6 months preceding this study or is unwilling to agree to abstain from smoking throughout the study;
- •Participation in another study with an investigational drug within the last 3 months preceding this study;
- •Blood donation within the last 2 months (>= 400 ml), or have a plan to donate blood within 1 month after this study;
- •Intake of any other drug which might influence the results of the trial during two weeks previous to the start of the study.
研究组 & 干预措施
Dexlansoprazole Injection
15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days
干预措施: Dexlansoprazole Injection (Drug)
Lansoprazole Injection
30 mg q12h in lansoprazole treatment arm for 5 days.
干预措施: Lansoprazole Injection (Drug)
结局指标
主要结局
Percentage time with the intragastric potential of hydrogen (pH)>4
时间窗: 24 hours post-dose on Day 5
Duration of intragastric pH\>4 within 24 hours postdose
Percentage time with the intragastric pH>6
时间窗: 24 hours post-dose on Day 5
Duration of intragastric pH\>6 within 24 hours postdose
The time of the intragastric pH reaching 4
时间窗: 12 hours post-dose on Day 5
The time of intragastric pH reaching 4 after the last dose
The time of the intragastric pH reaching 6
时间窗: 12 hours post-dose on Day 5
The time of intragastric pH reaching 6 after the last dose
次要结局
- Mean intragastric pH(24 hours post-dose on Day 5)
- Mean intragastric pH per hour(24 hours post-dose on Day 5)
- Percentage time with the intragastric pH>4 during the first 4 hours(4 hours post-dose on Day 5)
- Percentage time with the intragastric pH>6 during the first 4 hours(4 hours post-dose on Day 5)
- Percentage of the participants with duration time of intragastric pH>4 over 12h(12 hours post-dose on Day 5)
- Percentage of the participants with duration time of intragastric pH>6 over 12h(12 hours post-dose on Day 5)
- Cmax on day 1(12 hours post-dose on Day 5)
- Cmax on day 5(12 hours post-dose on Day 5)
- Area under the plasma concentration-time curve (AUC) on day 1(12 hours post-dose on Day 5)
- AUC(0-12h) on day 5(12 hours post-dose on Day 5)
- AUC(0-inf) on day 1(12 hours post-dose on Day 5)
- AUC(0-inf) on day 5(12 hours post-dose on Day 5)