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Recruiting NCT06578676

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

Phase I Interventional Type 2 Diabetes Dyslipidemias

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Empagliflozin 25 MG, Ezetimibe/Rosuvastatin 10/10mg, Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg.
Who it may be relevant to
Registry conditions: Type 2 Diabetes, Dyslipidemias. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Empagliflozin 25 MG
    PO, QD
  • Drug Ezetimibe/Rosuvastatin 10/10mg
    PO, QD
  • Drug Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg
    PO, QD

Primary outcome measures

  • 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 [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]
Secondary outcome measures (8)
  • 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 [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 [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 [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 [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 [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 [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 [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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

South Korea · 1 center
  • Kyungpook national university hospital — Daegu

Identifiers

NCT: NCT06578676 · HD-EZE-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗