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

Phase 1

Completed

• Conditions: Gastric Ulcer
• Interventions: Drug: BRI-1501; Drug: Lafutidine; Drug: Irsogladine maleate

• Registration Number: NCT02759224
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-15
• Study First Submitted: 2016-04-21
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-03
• Primary Completion: 2016-07-01
• Study Completion: 2016-12-29
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm A (Lafutidine and Irsogladine maleate --> BRI-1501)	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
Arm A (Lafutidine and Irsogladine maleate --> BRI-1501)	Lafutidine	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 A (Lafutidine and Irsogladine maleate --> BRI-1501)	Irsogladine maleate	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 B (BRI-1501 --> Lafutidine and Irsogladine maleate)	Lafutidine	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
Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)	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
Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)	BRI-1501	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Catholic University of Korea, Seoul St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of