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CompletedNCT02759224Updated Feb 7, 2017

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

A Phase 1 interventional study of BRI-1501 and Lafutidine in Gastric Ulcer, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-07.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
All
01

Study 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

02

Conditions studied

  • Gastric Ulcer

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03

In context

Stomach Ulcer

112 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.

This study's enrollment of 34 is below the median of 265 across 86 interventional studies indexed under Stomach Ulcer.

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Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subject, aged 19- 50 years

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • 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

Interventions

  • DrugBRI-1501
  • DrugLafutidine
  • DrugIrsogladine maleate
06

What researchers measure

Primary outcomes

  1. Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate

    Time frame: 0~36 hour after medication

  2. Area under the plasma drug concentration-time curve(AUClast) of Lafutidine and Irsogladine maleate

    Time frame: 0~36 hour after medication

07

Study locations

1 site
  • The Catholic University of Korea, Seoul St.Mary's Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02759224
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
May 3, 2016
Start date
Apr 15, 2016
Primary completion
Jul 1, 2016
Completion
Dec 29, 2016
Last update
Feb 7, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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