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

Boryung

Status and phase: Completed; Phase 1

Conditions: Gastric Ulcer

Treatments: Drug: Irsogladine maleate; Drug: Lafutidine; Drug: BRI-1501

Study type: Interventional

Funder types: Industry

Identifiers

NCT02759224

BR-LIC-CT-101

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

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

Other group

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

Treatment:

Drug: BRI-1501

Drug: Lafutidine

Drug: Irsogladine maleate

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

Other group

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

Treatment:

Drug: BRI-1501

Drug: Lafutidine

Drug: Irsogladine maleate