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

A Clinical Study to Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Dyslipidemias; Type 2 Diabetes
• Intervention / Treatment: Drug: Empagliflozin 25 MG; Drug: Ezetimibe/Rosuvastatin 10/10mg; Drug: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg

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 Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Young-Ran Yoon, PhD; Phone Number: +82 53-200-6351; Email: yry@knu.ac.kr

Study Locations

• Korea, Republic of
  • Gyeongsangbuk-do
    • Daegu, Gyeongsangbuk-do, Korea, Republic of
      • Recruiting
      • Kyungpook National University Hospital
      • Contact: Young-Ran Yoon, PhD; Phone Number: +82 53-200-6351; Email: yry@knu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Empagliflozin 25mg; 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; PO, QD; Drug: Ezetimibe/Rosuvastatin 10/10mg; PO, QD; Drug: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg; PO, QD
Experimental: Rosuvastatin/Ezetimibe 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; PO, QD; Drug: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg; PO, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hyundai Pharm
• Collaborators: Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Estimated): September 2, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Sodium-Glucose Transporter 2 Inhibitors; Rosuvastatin Calcium; Empagliflozin; Ezetimibe
• Other Study ID Numbers: HD-EZE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No