NCT03488186

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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).

Conditions

• Effect of Drugs
• Safety Issues

Interventions

Type	Name	Description
DRUG	Lansoprazole Capsules	24 healthy volunteers will be recruited and randomized into 2 groups (12 for each). During the study session, subjects will receive T drug in group A or R drug in group B for 7 days in fasted condition.

Timeline

• Start date: 2018-07-19
• Primary completion: 2018-10-11
• Completion: 2019-04-24
• First posted: 2018-04-04
• Last updated: 2019-08-16

Locations

1 site across 1 country: China