To Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults

Phase 1

Recruiting

• Conditions: Type 2 Diabetes; Dyslipidemias
• Interventions: Drug: Empagliflozin 25 MG; Drug: Ezetimibe/Rosuvastatin 10/10mg; Drug: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg

• Registration Number: NCT06578676
• Lead Sponsor: Hyundai Pharm

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-06-20
• Study First Submitted: 2024-07-04
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Primary Completion: 2024-09-02
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Signed informed consent
• Age: 19 and over , healthy volunteer
• Body mass index (BMI): 18.5≤BMI≤29.9 kg/m²

Exclusion Criteria

• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
• Clinically relevant findings(e.g. blood pressure, electrocardiogram(ECG); physical and gynecological examination, laboratory examination)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rosuvastatin/Ezetimibe 10/10mg	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)
Empagliflozin 25mg	Empagliflozin 25 MG	* Period 1: Empagliflozin (QD, 5d) * wash-out: 7d * Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)
Empagliflozin 25mg	Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg	* Period 1: Empagliflozin (QD, 5d) * wash-out: 7d * Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)
Rosuvastatin/Ezetimibe 10/10mg	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)
Empagliflozin 25mg	Ezetimibe/Rosuvastatin 10/10mg	* Period 1: Empagliflozin (QD, 5d) * wash-out: 7d * Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)

Primary Outcome Measures

Name	Time	Method
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	AUCtau,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	Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin

Secondary Outcome Measures

Name	Time	Method
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	Vdss/F 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	Tmax,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	t1/2,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin
Cmax,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	Cmax,ss, AUCtau,ss, AUCinf,ss, Tmax,ss, Cmin,ss, t1/2,ss, CLss/F, Vdss/F of Free ezetimibe
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	AUCinf,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	Cmin,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	AUCtau,ss 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	CLss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

Trial Locations

Locations (1)

Kyungpook national university hospital; 🇰🇷 Daegu, Gyeongsangbuk-do, Korea, Republic of