A Phase 1 interventional study of Empagliflozin 25 MG and Ezetimibe/Rosuvastatin 10/10mg in Type 2 Diabetes and Dyslipidemias, sponsored by Hyundai Pharm. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by Hyundai Pharm · Phase 1, Interventional, and Basic science
The purpose of this study is to evaluate pharmacokinetic interaction and safety of co-administrated 25mg of Empagliflozin and 10/10mg Ezetimibe/Rosuvastatin in steady state in healthy volunteers.
This trial is a phase 1 study to evaluate pharmacokinetic interaction and safety of co-administrated 25mg of Empagliflozin and 10/10mg of Ezetimibe/Rosuvastatin in steady state in healthy volunteers.
This is open-label, multiple-dose, two-arm, two-period and fixed-sequence design.
In Arm A, 18 subjects will be assigned. The subjects take 25mg of empagliflozin for 5days(Period 1). After 7days of washout period, the subjects take 10/10mg of Ezetimibe/Rosuvastatin for 2days and take co-administrated 25mg of Empagliflozin and 10/10mg of Ezetimibe/Rosuvastatin for 5days.
In Arm B, 38 subjects will be assigned. The subjects take 10/10mg of Ezetimibe/Rosuvastatin for 7days(Period 1). After 14days of washout period, the subjects take 25mg of empagliflozin for 2days and take co-administrated 25mg of Empagliflozin and 10/10mg of Ezetimibe/Rosuvastatin for 5days.
1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.
This study's planned enrollment of 56 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Hyundai Pharm is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Period 1: Empagliflozin (QD, 5d) * wash-out: 7d * Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)
Drug: Empagliflozin 25 MG · Drug: Ezetimibe/Rosuvastatin 10/10mg · Drug: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg
* Period 1: Ezetimibe/Rosuvastatin (QD, 7d) * wash-out: 14d * Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)
Drug: Ezetimibe/Rosuvastatin 10/10mg · Drug: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg
PO, QD
PO, QD
PO, QD
Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin
Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin
Time frame: 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
Time frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration
Vdss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin
Vdss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration
Plan to share: No
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