A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults (Part 1)

• Status: Completed
• Trial end date: 2017-03-09
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center, randomized, double-blind, dose-escalation, placebo-controlled phase 1 clinical trial. This study will determine the safety and side-effect profile of an investigational dexlansoprazole injection after single intravenous administration in healthy Chinese adults.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborators: Jiangsu Aosaikang Oharmaceutical Co. Ltd; Jiangsu Aosaikang Pharmaceutical Co., Ltd.
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

• Age ≥18 Years;

• Male (weight ≥50kg) or female (weight ≥45kg);

• BMI between 19~28 kg/m2;

• Healthy subjects (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.

Exclusion Criteria:

• 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;

• Medical examination, laboratory tests or ECG judged by the investigator to differ significantly from normal clinical values;

• HIV, HBV, or syphilis positive;

• Drug dependency or abuse;

• Heavy smokers (>5 cigarettes per day);

• Alcohol use;

• 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.