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Type 2 DiabetesPhase 1NCT06578676

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

A Phase 1 study testing Empagliflozin 25 MG, Ezetimibe/Rosuvastatin 10/10mg and Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg in people with Type 2 Diabetes and Dyslipidemias, run by Hyundai Pharm at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes, Dyslipidemias
What is being tested?
Empagliflozin 25 MG, Ezetimibe/Rosuvastatin 10/10mg and Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteSouth Korea
Study dates
20 Jun 2024to 30 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Age: 19 and over , healthy volunteer
  • Body mass index (BMI): 18.5≤BMI≤29.9 kg/m²

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Young-Ran Yoon, PhD contact

+82 53-200-6351

yry@knu.ac.kr

South Korea1 site, 1 recruiting

  • Kyungpook national university hospital

    Daegu, Gyeongsangbuk-do

    Young-Ran Yoon, PhD, +82 53-200-6351, yry@knu.ac.kr

    Recruiting

Other trials in South Korea

About this study

Official title: A Clinical Study 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.

Read the 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.

Being tested
Empagliflozin 25 MG, Ezetimibe/Rosuvastatin 10/10mg, Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg
Medical subject headings
Diabetes Mellitus, Type 2, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin 25 MGDrug

    PO, QD

  • Ezetimibe/Rosuvastatin 10/10mgDrug

    PO, QD

  • Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mgDrug

    PO, QD

Study groups in NCT06578676
Study groupRoleWhat they receive
Empagliflozin 25mgExperimental* Period 1: Empagliflozin (QD, 5d) * wash-out: 7d * Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)
Receives: Drug: Empagliflozin 25 MG; Drug: Ezetimibe/Rosuvastatin 10/10mg; Drug: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg
Rosuvastatin/Ezetimibe 10/10mgExperimental* Period 1: Ezetimibe/Rosuvastatin (QD, 7d) * wash-out: 14d * Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)
Receives: Drug: Ezetimibe/Rosuvastatin 10/10mg; Drug: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin

    Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin

    Measured: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48hours of after administration

  2. AUCtau,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin

    AUCtau,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin

    Measured: 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 (8)

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

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

    Measured: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

  2. Cmax,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

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

    Measured: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

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

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

    Measured: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

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

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

    Measured: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

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

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

    Measured: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

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

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

    Measured: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

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

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

    Measured: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

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

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

    Measured: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2024
  2. Study start20 Jun 2024
  3. Primary completion2 Sep 2024 (estimated)
  4. Study completion30 Nov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
2 sequence
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06578676
Sponsor's protocol ID
HD-EZE-01
Status last verified
Aug 2024
First submitted
4 Jul 2024
Last updated
29 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Empagliflozin 25 MG, Ezetimibe/Rosuvastatin 10/10mg and Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg in people with Type 2 Diabetes and Dyslipidemias, run by Hyundai Pharm at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Young-Ran Yoon, PhD (+82 53-200-6351, yry@knu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06578676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.

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