NCT02581696

The Drug-drug Interaction and Safety of Lafutidine and Irsogladine Maleate in Healthy Adult Volunteers

An Open-label, Multiple-dose, Single-arm, Phase 1 Study to Evaluate the Drug-drug Interaction and Safety of Lafutidine and Irsogladine Maleate in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

An open-label, multiple-dose, single-arm, phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers

Detailed description

A phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers. Subjects judged to be appropriate to this study by screening before 28days of first administration. Subjects administrate Lafutidine bid during period I. After wash-out period, administrate Irsogladine maleate qd during Period II. After than, coadministration Lafutidine bid and Irsogladine maleate qd.

Conditions

• Peptic Ulcer

Interventions

Type	Name	Description
DRUG	Lafutidine	Lafutidine 10mg, 1 tablet, bid
DRUG	Irsogladine maleate	Irsogladine maleate 2mg, 2 tablet, qd

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-10-21
• Last updated: 2017-02-06

Locations

1 site across 1 country: South Korea