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PK-PD Comparative Study of Lansoprazole Capsules and Lansoprazole Enteric-coated Capsules in Healthy Chinese Volunteers

Safety Issues Clinical Trial

Official title:
A Randomized, Open Label, Parallel, Single and Multiple Doses Designed Clinical Study to Evaluate Comparative Pharmacokinetics (PK)-Pharmacodynamics (PD) After Oral Administration of Lansoprazole Capsules and Lansoprazole Enteric-coated Capsules in Healthy Chinese Volunteers

Clinical Trial Summary

The objective of this study was to compare the relative PK-PD of Lansoprazole Capsules and Lansoprazole DR Capsules in healthy Chinese volunteers.

Clinical Trial Description

This is a randomized, open Label, parallel, single and multiple doses designed clinical trial. This study will determine the pharmacokinetics (PK), pharmacodynaimcs (PD) and safety after oral administration of an investigational Lansoprazole Capsules in healthy Chinese volunteers.

This study will enroll 24 healthy adults with 12 cases in each group (male : female=1:1). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03488186
Study type Interventional
Source First Affiliated Hospital of Zhejiang University
Contact
Status Completed
Phase Phase 1
Start date July 19, 2018
Completion date April 24, 2019
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