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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2024-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Type 2 Diabetes Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

2 sequence

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Empagliflozin 25mg

* Period 1: Empagliflozin (QD, 5d)
* wash-out: 7d
* Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)

Group Type EXPERIMENTAL

Empagliflozin 25 MG

Intervention Type DRUG

PO, QD

Ezetimibe/Rosuvastatin 10/10mg

Intervention Type DRUG

PO, QD

Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg

Intervention Type DRUG

PO, QD

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)

Group Type EXPERIMENTAL

Ezetimibe/Rosuvastatin 10/10mg

Intervention Type DRUG

PO, QD

Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg

Intervention Type DRUG

PO, QD

Interventions

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Empagliflozin 25 MG

PO, QD

Intervention Type DRUG

Ezetimibe/Rosuvastatin 10/10mg

PO, QD

Intervention Type DRUG

Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg

PO, QD

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes