A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults（Part 2）

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-05

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Effect of Drugs Safety Issues

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexlansoprazole Injection

15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days

Group Type EXPERIMENTAL

Dexlansoprazole Injection

Intervention Type DRUG

15mg q12h,30mg q12h,15mg qd,30mg qd for 5 days

Lansoprazole Injection

30 mg q12h in lansoprazole treatment arm for 5 days.

Group Type ACTIVE_COMPARATOR

Lansoprazole Injection

Intervention Type DRUG

30 mg q12h for 5 days.

Interventions

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Dexlansoprazole Injection

15mg q12h,30mg q12h,15mg qd,30mg qd for 5 days

Intervention Type DRUG

Lansoprazole Injection

30 mg q12h for 5 days.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes