Clinical Trial Details
| Trial ID: | L5341 |
| Source ID: | NCT03867942 |
| Associated Drug: | Monolayer Group |
| Title: | BE Study of Bilayer Combination of Gemigliptin/Rosuvastatin 50/20mg in Comparison to Monolayer Combination. |
| Acronym: | |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2|Dyslipidemias |
| Interventions: | DRUG: Monolayer group|DRUG: Bilayer group |
| Outcome Measures: | Primary: Gemigliptin AUC, Gemigliptin, 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour|Rosuvastain AUC, Rosuvastain, 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour|Rosuvastain Cmax, Rosuvastain, 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour|Gemigliptin Cmax, Gemigliptin, 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour | |
| Sponsor/Collaborators: | Sponsor: LG Chem |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 48 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2019-03-21 |
| Completion Date: | 2019-08-31 |
| Results First Posted: | |
| Last Update Posted: | 2019-03-08 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT03867942 |
