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

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

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03120273
Study type Interventional
Source First Affiliated Hospital of Zhejiang University
Contact Lihua Wu, Doctor
Phone 86-13819195192
Email lihuawu73@163.com
Status Recruiting
Phase Phase 1
Start date May 5, 2017
Completion date September 30, 2017
View Details
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