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NCT Number: NCT06578676

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook national university hospital

Daegu, Gyeongsangbuk-do, South Korea

Location status: Recruiting

Location contact

Young-Ran Yoon, PhD

CONTACT

[email protected]

+82 53-200-6351

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Empagliflozin 25 MG

Drug

PO, QD

Ezetimibe/Rosuvastatin 10/10mg

Drug

PO, QD

Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg

Drug

PO, QD

Primary outcomes

  1. 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

    Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin

  2. 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

    AUCtau,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin

Secondary outcomes

  1. 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

    Vdss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

  2. 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

    Cmax,ss, AUCtau,ss, AUCinf,ss, Tmax,ss, Cmin,ss, t1/2,ss, CLss/F, Vdss/F of Free ezetimibe

  3. 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

    AUCtau,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

  4. 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

    AUCinf,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

  5. 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

    Tmax,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

  6. 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

    Cmin,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

  7. 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

    t1/2,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

  8. 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

    CLss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

Study contacts

Contact information is provided by the study sponsor or research team.

Young-Ran Yoon, PhD

CONTACT

[email protected]

+82 53-200-6351

Sponsors and collaborators

Lead sponsor

Hyundai Pharm

Industry

Collaborators

  • Kyungpook National University Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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