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Healthy SubjectsPhase 1NCT05823870

This Study is to Compare and Evaluate the Safety and Pharmacokinetic Characteristics (PK) After Administration of DW6014 and Each Component(Empagliflozin and Metformin) in Healthy Adult Volunteers in Fast Condition.

A Phase 1 study testing DW6014 in people with Healthy Subjects, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6014 and each component in healthy adult volunteers in fast condition. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
DW6014
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSouth Korea
Study dates
24 Feb 2023to 20 Mar 2023
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

  • Healthy subjects aged up to 19 years
  • Subjects weighing at least 50.0 kg with a BMI between 18.0 kg/m2 and 30.0 kg/m2
  • Subjects with neither congenital nor chronic diseases requiring treatment, and no abnormal symptoms or findings upon medical examination
  • Subjects considered eligible for the study participation in accordance to the results of clinical laboratory tests, vital signs, physical examinations and 12-lead ECG conducted at the time of screening, based on the investigational product (IP) characteristics
  • Subjects who has a full understanding in participation of the study, voluntarily provide a written consent in participation, and give full agreement in following the subject guidelines throughout the entire study period

Who cannot join

  • Subjects with any clinically significant hepatic, renal, nervous, respiratory, endocrine, circulatory, tumor, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases or other medical history
  • Subject with galactose intolerance, Lapp lactase deficience, glucose-galactose malabsorption or other genetic problem
  • Subject following gastrointestinal diseases or gastrointestinal surgery that may affect the absorption of the IP
  • Pregnant subjects with a positive urine HCG(human chorionic gonadotropin) test, or lactating female subjects
  • Subject with a medical history of hypersensitivity reactions (anaphylaxis or antibiotics etc.) to containing empagliflozin and metformin components, formulation additives, and other drugs (aspirin, antibiotics, biguanide drugs, etc.) or clinically significant hypersensitivity reactions
  • Subjects with clinically significant 12-lead ECG findings at the time of screening
Show all 20Show fewer
  • Subjects with a past history of drug abuse or a positive urine drug test
  • Subjects with SBP(systolic blood pressure) ≥ 150 mmHg or ≤ 90 mmHg; DBP(diastolic blood pressure) ≥ 100 mmHg or ≤ 60 mmHg; Pulse Rate ≤ 40 bpm or ≥ 100 bpm at the time of screening
  • Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals within 1 months prior to the first IP administration
  • Subjects who have administered any prescription drugs or herbal medicines that may affect the characteristics of clinical investigational drugs within 2 weeks prior to the first administration date, or have administered any over-the-counter (OTC) or vitamin preparations within 10 days
  • Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals within 1 months prior to the first IP administration
  • Subjects who have participated and were given any other study drugs in other clinical study within 6 months prior to the first IP administration
  • Before the first administration date whole blood donation within 2 months or component blood donation within 1 month or received a blood transfusion within 1 month, or the subject who cannot forbid transfusion from the time of obtaining ICF(informed consent form) until PSV(Post-study visit)
  • Subjects who have consistently drunk alcohol within 6 months
  • Subjects who have smoked more than 10 cigarettes/day on average
  • Subjects who have eaten or cannot refrain from eating grapefruit (grapefruit)-containing food from 48 hours before the first administration until the time of PSV(Post-study visit)
  • Subjects who have consumed or cannot refrain from consuming caffeine-containing food during the period from 24 hours prior to administration of each period to the time of the last blood sampling
  • Subjects who have done and are unable to refrain from strenuous activity
  • Subjects who are planning for pregnancy or not willing to use a medically reliable forms of contraception
  • Subjects otherwise considered ineligible for participation due to other reasons including clinical laboratory test results not mentioned in the inclusion/exclusion criteria at the investigator's discretion

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chungbuk National University Hospital

    Cheongju-si

Other trials in South Korea

About this study

Official title: A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination of DW6014 and Loose Combination of Each Component in Healthy Adult Volunteers in Fasted Condition

This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6014 and each component in healthy adult volunteers in fast condition.

Read the detailed description

This is a Phase 1, randomized, open-label, Oral, Single-dose, two-way crossover study in healthy subjects.

Being tested
DW6014

What participants receive

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

  • DW6014Drug

    Also called Empagliflozin and Metformin

    Drug: DW6014 Single oral administration of DW6014 after an overnight fast

    Drug: Empagliflozin and Metformin Combination oral administration of Empagliflozin and Metformin after an overnight fast

Study groups in NCT05823870
Study groupRoleWhat they receive
Sequence AExperimentalPeriod 1: Empagliflozin and Metformin Period 2: DW6014
Receives: Drug: DW6014
Sequence BExperimentalPeriod 1: DW6014 Period 2: Empagliflozin and Metformin
Receives: Drug: DW6014

What is being measured

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

  1. AUC0-t

    AUC0-t of Empagliflozin and Metformin

    Measured: 48 hour

  2. Cmax

    Cmax of Empagliflozin and Metformin

    Measured: 48 hour

Secondary outcomes (5)

  1. Tmax

    Tmax of Empagliflozin and Metformin

    Measured: 48 hour

  2. AUCinf administration to infinity)

    AUCinf of Empagliflozin and Metformin

    Measured: 48 hour

  3. t1/2

    t1/2 of Empagliflozin and Metformin

    Measured: 48 hour

  4. CL/F

    CL/F of Empagliflozin and Metformin

    Measured: 48 hour

  5. Vd/F

    Vd/F of Empagliflozin and Metformin

    Measured: 48 hour

Timeline

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

  1. First posted21 Apr 2023
  2. Study start24 Feb 2023
  3. Primary completion6 Mar 2023
  4. Study completion20 Mar 2023

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05823870
Sponsor's protocol ID
DW6014-I-1
Status last verified
May 2023
First submitted
10 Apr 2023
Last updated
26 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DW6014 in people with Healthy Subjects, run by Dong Wha Pharmaceutical Co. Ltd. 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 5 inclusion and 20 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: finished, as of the sponsor's last update on 26 May 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-t (time frame: 48 hour). 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 NCT05823870.

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 26 May 2023.

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Clinical Trial NCT05823870 | AzTrials