Clinical Trial Details
| Trial ID: | L4915 |
| Source ID: | NCT06492655 |
| Associated Drug: | Ckd-383(Fed) |
| Title: | To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers |
| Acronym: | |
| Status: | NOT_YET_RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: CKD-383(Fed)|DRUG: CKD-383(Fasted) |
| Outcome Measures: | Primary: AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2), Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration|Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2), Pharmacokinetic characterization, 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: | 2024-07-04 |
| Completion Date: | 2024-08-08 |
| Results First Posted: | |
| Last Update Posted: | 2024-07-10 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT06492655 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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