| Registry | NCT02759224 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 34 (Actual) |
| Sponsor | Boryung Pharmaceutical Co., Ltd (Industry) |
| Conditions | Gastric Ulcer |
| Interventions | BRI-1501, Lafutidine, Irsogladine maleate (Drug) |
| Dates | start 2016-04-15, primary completion 2016-07-01, completion 2016-12-29, first posted 2016-05-03, last updated 2017-02-07 |
| Locations | 1 site in South Korea |
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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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm A (Lafutidine and Irsogladine maleate --> BRI-1501) | Other | Drug: BRI-1501; Drug: Lafutidine; Drug: 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) | Other | Drug: BRI-1501; Drug: Lafutidine; Drug: 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 |
Sex: All, ages: 19 Years to 50 Years, 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
| Facility | City | Country | Status |
|---|---|---|---|
| The Catholic University of Korea, Seoul St.Mary's Hospital | Seoul | South Korea |