Clinical Trial Details
| Trial ID: | L6315 |
| Source ID: | NCT06204107 |
| Associated Drug: | Ckd-379(Empagliflozin+Sitagliptin+Metformin) Test Drug |
| Title: | A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379 |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug|DRUG: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug |
| Outcome Measures: | Primary: AUCt of Empagliflozin, sitagliptin, metformin, 0 hour ~ 48 hour after drug administration|Cmax of Empagliflozin, sitagliptin, metformin, 0 hour ~ 48 hour after drug administration | Secondary: AUCinf of Empagliflozin, sitagliptin, metformin, 0 hour ~ 48 hour after drug administration|Tmax of Empagliflozin, sitagliptin, metformin, 0 hour ~ 48 hour after drug administration|t1/2 of Empagliflozin, sitagliptin, metformin, 0 hour ~ 48 hour after drug administration|CL/F of Empagliflozin, sitagliptin, metformin, 0 hour ~ 48 hour after drug administration|Vd/F of Empagliflozin, sitagliptin, metformin, 0 hour ~ 48 hour after drug administration |
| Sponsor/Collaborators: | Sponsor: Chong Kun Dang Pharmaceutical |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 28 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2023-11-21 |
| Completion Date: | 2023-12-06 |
| Results First Posted: | |
| Last Update Posted: | 2024-01-12 |
| Locations: | Seoul National University Bundang Hospital, Seongnam, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT06204107 |
