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

Hyundai Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Dyslipidemias; Type 2 Diabetes

Treatments: Drug: Ezetimibe/Rosuvastatin 10/10mg; Drug: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg; Drug: Empagliflozin 25 MG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06578676

HD-EZE-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Empagliflozin 25mg

Experimental group

Description:

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

Treatment:

Drug: Empagliflozin 25 MG

Drug: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg

Drug: Ezetimibe/Rosuvastatin 10/10mg

Rosuvastatin/Ezetimibe 10/10mg

Experimental group

Description:

* Period 1: Ezetimibe/Rosuvastatin (QD, 7d) * wash-out: 14d * Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)

Treatment:

Drug: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg

Drug: Ezetimibe/Rosuvastatin 10/10mg