Effect of Drugs, Safety Issues
Conditions
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.
Interventions
15mg q12h,30mg q12h,15mg qd,30mg qd for 5 days
DRUGLansoprazole Injection
30 mg q12h for 5 days.
Sponsors
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
First Affiliated Hospital of Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| AUC(0-inf) on day 5 | 12 hours post-dose on Day 5 | AUC from time 0 to extrapolated to infinity on day 5 |
| 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 |
| Cmax on day 5 | 12 hours post-dose on Day 5 | Maximum observed plasma concentration for dexlansoprazole |
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactLihua Wu, Doctor
Outcome results
None listed