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

NCT03120273 ↗

Phase 1 Unknown 70 enrolled First Affiliated Hospital of Zhejiang University Jiangsu Aosaikang Pharmaceutical Co., Ltd. · collab

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2017-05-05
Primary completion: 2017-08-31
Completion: 2017-09-30

Publications

Wu L, Liu J, Zheng Y, Zhai Y, Lin M, Wu G, Lv D, Shentu J. Pharmacokinetic/Pharmacodynamic Evaluation of Dexlansoprazole Infusion Injection Compared with Lansoprazole in Healthy Chinese Adults. Clin Drug Investig. 2019 Oct;39(10):953-965. doi: 10.1007/s40261-019-00824-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexlansoprazole	Other / unclassified	15 mg	Intravenous
Subject	Dexlansoprazole	Other / unclassified	30 mg	Intravenous
Comparator	Lansoprazole	Other / unclassified	30 mg	—

Indications

No indication recorded.