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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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 Summary: 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.
Sponsor: Boryung Pharmaceutical Co., Ltd

Current Primary Outcome: Area under the plasma concentration versus time curve of Lafutidine and Irsogladine maleate [ Time Frame: Sampling time 1, 19, 21days before drug administration, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hr after drug administration. (total 24times) ]

Original Primary Outcome:

  • Area under the plasma concentration versus time curve of Lafutidine and Irsogladine maleate [ Time Frame: Sampling time 1, 19, 21days before drug administration, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hr after drug administration. (total 24times) ]
  • Peak Plasma Concentration of Lagutidine and Irsogladine [ Time Frame: Sampling time 1, 19, 21days before drug administration, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hr after drug administration. (total 24times) ]


Current Secondary Outcome: Peak Plasma Concentration of Lafutidine and Irsogladine [ Time Frame: Sampling time 1, 19, 21days before drug administration, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hr after drug administration. (total 24times) ]

Original Secondary Outcome:

Information By: Boryung Pharmaceutical Co., Ltd

Dates:
Date Received: October 12, 2015
Date Started: August 2015
Date Completion:
Last Updated: February 3, 2017
Last Verified: February 2017