Clinical Trial Details
| Trial ID: | L4954 |
| Source ID: | NCT06483243 |
| Associated Drug: | Test: Ckd-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance Tablets 25 Mg, Reference3: Glucophage Xr Tab. 1000mg |
| Title: | Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic of CKD-501, D745, and D150 for Healthy Subjects in Fed State. |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG |
| Outcome Measures: | Primary: AUCt of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration|Cmax of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration | Secondary: AUC∞ of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration|Tmax of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration|T1/2 of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration|CL/F of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration|Vd/F of Lobeglitazone, Empagliflozin, Metformin, Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration |
| Sponsor/Collaborators: | Sponsor: Chong Kun Dang Pharmaceutical |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 45 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2024-04-04 |
| Completion Date: | 2024-05-17 |
| Results First Posted: | |
| Last Update Posted: | 2024-07-03 |
| Locations: | Chung-Ang University Gwangmyeong Hospital, Gyeonggi-do, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT06483243 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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