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

NCT03011125 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-03-16

No results posted yet for this study

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.

Conditions

  • Safety Issues

Interventions

DRUG

dexlansoprazole injection

OTHER

placebo

Sponsors & Collaborators

  • Jiangsu Aosaikang Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Lihua Wu, Doctor · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-03-09
Completion
2017-03-09

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03011125 on ClinicalTrials.gov