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Clinical Trial Details

Trial ID: L1971
Source ID: NCT06578676
Associated Drug: Empagliflozin 25 Mg
Title: To Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Dyslipidemias
Interventions: DRUG: Empagliflozin 25 MG|DRUG: Ezetimibe/Rosuvastatin 10/10mg|DRUG: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg
Outcome Measures: Primary: Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin, Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48hours of after administration|AUCtau,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin, AUCtau,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration | Secondary: Vdss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, Vdss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|Cmax,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, Cmax,ss, AUCtau,ss, AUCinf,ss, Tmax,ss, Cmin,ss, t1/2,ss, CLss/F, Vdss/F of Free ezetimibe, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|AUCtau,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, AUCtau,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|AUCinf,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, AUCinf,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|Tmax,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, Tmax,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|Cmin,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, Cmin,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|t1/2,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, t1/2,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|CLss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, CLss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration
Sponsor/Collaborators: Sponsor: Hyundai Pharm | Collaborators: Kyungpook National University Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 56
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-20
Completion Date: 2024-11-30
Results First Posted:
Last Update Posted: 2024-08-29
Locations: Kyungpook national university hospital, Daegu, Gyeongsangbuk-do, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT06578676

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress