Safety Issues Clinical Trial
Official title:
A Phase 1 Clinical Trial to Evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety in Healthy Chinese Adults After Multiple Intravenous Administration of Dexlansoprazole
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | September 30, 2017 |
Est. primary completion date | August 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | First affiliated hospital of Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Zhejiang University | Jiangsu Aosaikang Pharmaceutical Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage time with the intragastric potential of hydrogen (pH)>4 | Duration of intragastric pH>4 within 24 hours postdose | 24 hours post-dose on Day 5 | |
Primary | Percentage time with the intragastric pH>6 | Duration of intragastric pH>6 within 24 hours postdose | 24 hours post-dose on Day 5 | |
Primary | The time of the intragastric pH reaching 4 | The time of intragastric pH reaching 4 after the last dose | 12 hours post-dose on Day 5 | |
Primary | The time of the intragastric pH reaching 6 | The time of intragastric pH reaching 6 after the last dose | 12 hours post-dose on Day 5 | |
Secondary | Mean intragastric pH | Mean intragastric pH | 24 hours post-dose on Day 5 | |
Secondary | Mean intragastric pH per hour | Mean intragastric pH per hour | 24 hours post-dose on Day 5 | |
Secondary | Percentage time with the intragastric pH>4 during the first 4 hours | Duration of intragastric pH>4 within first 4 hours postdose | 4 hours post-dose on Day 5 | |
Secondary | Percentage time with the intragastric pH>6 during the first 4 hours | Duration of intragastric pH>6 within first 4 hours postdose | 4 hours post-dose on Day 5 | |
Secondary | Percentage of the participants with duration time of intragastric pH>4 over 12h | Numbers of participants with duration time of intragastric pH>4 over 12h | 12 hours post-dose on Day 5 | |
Secondary | Percentage of the participants with duration time of intragastric pH>6 over 12h | Numbers of participants with duration time of intragastric pH>6 over 12h | 12 hours post-dose on Day 5 | |
Secondary | Cmax on day 1 | Maximum observed plasma concentration for dexlansoprazole | 12 hours post-dose on Day 5 | |
Secondary | Cmax on day 5 | Maximum observed plasma concentration for dexlansoprazole | 12 hours post-dose on Day 5 | |
Secondary | Area under the plasma concentration-time curve (AUC) on day 1 | AUC from time 0 to the time of the last quantifiable concentration on day 1 | 12 hours post-dose on Day 5 | |
Secondary | AUC(0-12h) on day 5 | AUC from time 0 to the time of the last quantifiable concentration on day 5 | 12 hours post-dose on Day 5 | |
Secondary | AUC(0-inf) on day 1 | AUC from time 0 to extrapolated to infinity on day 1 | 12 hours post-dose on Day 5 | |
Secondary | AUC(0-inf) on day 5 | AUC from time 0 to extrapolated to infinity on day 5 | 12 hours post-dose on Day 5 |
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