A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet

February 6, 2017 updated by: Boryung Pharmaceutical Co., Ltd
An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual Tablets in Healthy Adult Volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • The Catholic University of Korea, Seoul St.Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subject, aged 19- 50 years

Exclusion Criteria:

  • History of clinically significant and active disease
  • History of gastrointestinal disease
  • History of clinically significant hypersensitivity to study drug, any other drug
  • Laboratory test serum AST or ALT > 1.25 times of upper normal range serum total bilirubin > 1.5 times of upper normal range eGFR < 60 ml/min/1.73m² serological test(HBsAg, HCV Ab, HIV Ag/Ab, Syphilis reagin) positive
  • Hypotension or hypertension
  • Pregnant or nursing women
  • Participation in any other study within 90 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm A (Lafutidine and Irsogladine maleate --> BRI-1501)
Subjects of Arm A take Lafutidine and Irsogladine maleate Individual tablets at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm A take a BRI-1501 tablet at 36th day
Drug: BRI-1501
Drug: Lafutidine
Drug: Irsogladine maleate
Other: Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)
Subjects of Arm B take a BRI-1501 tablet at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm B take Lafutidine and Irsogladine maleate Individual tablets at 36th day
Drug: BRI-1501
Drug: Lafutidine
Drug: Irsogladine maleate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate
Time Frame: 0~36 hour after medication
0~36 hour after medication
Area under the plasma drug concentration-time curve(AUClast) of Lafutidine and Irsogladine maleate
Time Frame: 0~36 hour after medication
0~36 hour after medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 29, 2016

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-LIC-CT-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Ulcer

Clinical Trials on BRI-1501

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe