Clinical Trial Details
| Trial ID: | L7344 |
| Source ID: | NCT01780051 |
| Associated Drug: | Repaglinide/Metformin Combination, Repaglinide, Metformin |
| Title: | A Pharmacokinetic Study to Compare Co-administration of Repaglinide and Metformin HCl to Administration of Combination Preparation of Those Two Components |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Repaglinide/Metformin combination, Repaglinide, Metformin|DRUG: Repaglinide/Metformin combination, Repaglinide, Metformin |
| Outcome Measures: | Primary: AUCt and Cmax of repaglinide and metformin, Before study drug administration(0h) and after 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h of study drug administration. | Secondary: AUC∞, Tmax, t1/2, CL/F and Vd/F of repaglinide and metformin, Before study drug administration(0h) and after 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h of study drug administration. |
| Sponsor/Collaborators: | Sponsor: Dalim BioTech Co., Ltd. |
| Gender: | MALE |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 48 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2013-03 |
| Completion Date: | 2013-04 |
| Results First Posted: | |
| Last Update Posted: | 2013-05-15 |
| Locations: | Chounbuk National University Hospital, Jeonju, Jeonbuk, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT01780051 |
