Clinical trial NCT06578676: To Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults
Official title: A Clinical Study to Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Type 2 Diabetes
Dyslipidemias
Lead sponsor: Hyundai Pharm
Sponsor class: INDUSTRY
Collaborators: name: Kyungpook National University Hospital
First posted: 2024-08-29
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 sequence
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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)

Primary outcomes:
measure: Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin
timeFrame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48hours of after administration
measure: AUCtau,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin
timeFrame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration
Secondary outcomes:
measure: Vdss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin
timeFrame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration
measure: Cmax,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin
timeFrame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration
measure: AUCtau,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin
timeFrame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration
measure: AUCinf,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin
timeFrame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration
measure: Tmax,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin
timeFrame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration
measure: Cmin,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin
timeFrame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration
measure: t1/2,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin
timeFrame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration
measure: CLss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin
timeFrame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university hospital
state: Gyeongsangbuk-do
Study officials:
References: