A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults（Part 2）
- Conditions
- Safety IssuesEffect of Drugs
- Interventions
- Registration Number
- NCT03120273
- Lead Sponsor
- First Affiliated Hospital of Zhejiang University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexlansoprazole Injection Dexlansoprazole Injection 15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days Lansoprazole Injection Lansoprazole Injection 30 mg q12h in lansoprazole treatment arm for 5 days.
- Primary Outcome Measures
Name Time Method Percentage time with the intragastric potential of hydrogen (pH)>4 24 hours post-dose on Day 5 Duration of intragastric pH\>4 within 24 hours postdose
Percentage time with the intragastric pH>6 24 hours post-dose on Day 5 Duration of intragastric pH\>6 within 24 hours postdose
The time of the intragastric pH reaching 4 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 12 hours post-dose on Day 5 The time of intragastric pH reaching 6 after the last dose
- Secondary Outcome Measures
Name Time Method Cmax on day 5 12 hours post-dose on Day 5 Maximum observed plasma concentration for dexlansoprazole
Mean intragastric pH 24 hours post-dose on Day 5 Mean intragastric pH
Mean intragastric pH per hour 24 hours post-dose on Day 5 Mean intragastric pH per hour
Percentage time with the intragastric pH>4 during the first 4 hours 4 hours post-dose on Day 5 Duration of intragastric pH\>4 within first 4 hours postdose
Percentage time with the intragastric pH>6 during the first 4 hours 4 hours post-dose on Day 5 Duration of intragastric pH\>6 within first 4 hours postdose
Percentage of the participants with duration time of intragastric pH>4 over 12h 12 hours post-dose on Day 5 Numbers of participants with duration time of intragastric pH\>4 over 12h
Percentage of the participants with duration time of intragastric pH>6 over 12h 12 hours post-dose on Day 5 Numbers of participants with duration time of intragastric pH\>6 over 12h
Cmax on day 1 12 hours post-dose on Day 5 Maximum observed plasma concentration for dexlansoprazole
Area under the plasma concentration-time curve (AUC) on day 1 12 hours post-dose on Day 5 AUC from time 0 to the time of the last quantifiable concentration on day 1
AUC(0-12h) on day 5 12 hours post-dose on Day 5 AUC from time 0 to the time of the last quantifiable concentration on day 5
AUC(0-inf) on day 1 12 hours post-dose on Day 5 AUC from time 0 to extrapolated to infinity on day 1
AUC(0-inf) on day 5 12 hours post-dose on Day 5 AUC from time 0 to extrapolated to infinity on day 5
Trial Locations
- Locations (1)
First affiliated hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China