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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-15

Study Completion Date

2016-12-29

Brief Summary

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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

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Detailed Description

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Conditions

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Gastric Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

BRI-1501

Intervention Type DRUG

Lafutidine

Intervention Type DRUG

Irsogladine maleate

Intervention Type DRUG

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

Group Type OTHER

BRI-1501

Intervention Type DRUG

Lafutidine

Intervention Type DRUG

Irsogladine maleate

Intervention Type DRUG

Interventions

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BRI-1501

Intervention Type DRUG

Lafutidine

Intervention Type DRUG

Irsogladine maleate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes