Back to resultsA Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet
Primary Purpose
Gastric Ulcer
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BRI-1501
Lafutidine
Irsogladine maleate
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Ulcer
Eligibility Criteria
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
Sites / Locations
- The Catholic University of Korea, Seoul St.Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Arm A (Lafutidine and Irsogladine maleate --> BRI-1501)
Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)
Arm Description
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
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
Outcomes
Primary Outcome Measures
Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate
Area under the plasma drug concentration-time curve(AUClast) of Lafutidine and Irsogladine maleate
Secondary Outcome Measures
Full Information
NCT ID
NCT02759224
First Posted
April 21, 2016
Last Updated
February 6, 2017
Sponsor
Boryung Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02759224
Brief Title
A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 15, 2016 (Actual)
Primary Completion Date
July 1, 2016 (Actual)
Study Completion Date
December 29, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A (Lafutidine and Irsogladine maleate --> BRI-1501)
Arm Type
Other
Arm Description
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
Arm Title
Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
BRI-1501
Intervention Type
Drug
Intervention Name(s)
Lafutidine
Intervention Type
Drug
Intervention Name(s)
Irsogladine maleate
Primary Outcome Measure Information:
Title
Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate
Time Frame
0~36 hour after medication
Title
Area under the plasma drug concentration-time curve(AUClast) of Lafutidine and Irsogladine maleate
Time Frame
0~36 hour after medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The Catholic University of Korea, Seoul St.Mary's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet
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