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

NCT02759224 | Completed Phase 1

• 1 other identifier: BR-LIC-CT-101
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Ulcer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Arm A (Lafutidine and Irsogladine maleate --> BRI-1501)

OTHER

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

Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)

OTHER

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

BRI-1501 DRUG

Arm A (Lafutidine and Irsogladine maleate --> BRI-1501); Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)

Lafutidine DRUG

Arm A (Lafutidine and Irsogladine maleate --> BRI-1501); Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)

Irsogladine maleate DRUG

Arm A (Lafutidine and Irsogladine maleate --> BRI-1501); Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subject, aged 19- 50 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Ulcer

Interventions

lafutidine; irsogladine

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: May 3, 2016
• Study Start: April 15, 2016
• Primary Completion: July 1, 2016
• Study Completion: December 29, 2016
• Last Updated: February 7, 2017

Record last verified: 2017-02

Locations

KR (1)