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

• Status: Completed
• Trial end date: 2016-12-29
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Treatments: Irsogladine; Lafutidine; Maleic acid

Criteria

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