Gastric Ulcer
Conditions
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
Interventions
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed