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

Zhejiang University

Status and phase: Unknown; Phase 1

Conditions: Effect of Drugs; Safety Issues

Treatments: Drug: Lansoprazole Injection; Drug: Dexlansoprazole Injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03120273

ASKC263-LC-1-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Dexlansoprazole Injection

Experimental group

Description:

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

Treatment:

Drug: Dexlansoprazole Injection

Lansoprazole Injection

Active Comparator group

Description:

30 mg q12h in lansoprazole treatment arm for 5 days.

Treatment:

Drug: Lansoprazole Injection