DW6014Phase 1NCT05823883

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 Fed Condition.

A Phase 1 study testing DW6014 in people with DW6014, run by Dong Wha Pharmaceutical Co. Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.

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 fed condition. Read more about this study

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: DW6014
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: 30 participants
Where: 1 siteSouth Korea
Study dates: Jun 2023to Aug 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 19Show 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 Fed 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 fed condition.

Read the detailed description

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

Conditions: DW6014
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 in fed condition
Drug: Empagliflozin and Metformin Combination oral administration of Empagliflozin and Metformin in fed condition

Study groups in NCT05823883
Study group	Role	What they receive
Sequence A	Experimental	Period 1: Empagliflozin and Metformin Period 2: DW6014 Receives: Drug: DW6014
Sequence B	Experimental	Period 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.

AUC0-t
AUC0-t of Metformin
Measured: 48 hour
Cmax
Cmax of Metformin
Measured: 48 hour

Secondary outcomes (5)

Tmax
Tmax of Metformin
Measured: 48 hour
AUCinf
AUCinf of Metformin
Measured: 48 hour
t1/2
t1/2 of Metformin
Measured: 48 hour
CL/F
CL/F of Metformin
Measured: 48 hour
Vd/F
Vd/F of 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.

Jun 2023Aug 2023

First posted21 Apr 2023
Study startJun 2023 (estimated)
Primary completionJul 2023 (estimated)
Study completionAug 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DW6014Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05823883
Sponsor's protocol ID: DW6014-I-2
Status last verified: Apr 2023
First submitted: 10 Apr 2023
Last updated: 26 May 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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 Fed Condition
ClinicalTrials.gov ID: NCT05823883
Acronym / sponsor ID: DW6014-I-2
Conditions: DW6014
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Dong Wha Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
Study start: Jun 2023 (estimated)
Primary completion: Jul 2023 (estimated)
Study completion: Aug 2023 (estimated)
First posted: 21 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 fed condition.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence A	Experimental	Drug: DW6014Period 1: Empagliflozin and Metformin Period 2: DW6014
Sequence B	Experimental	Drug: DW6014Period 1: DW6014 Period 2: Empagliflozin and Metformin

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DW6014Also: Empagliflozin and MetforminDrug: DW6014 Single oral administration of DW6014 in fed condition Drug: Empagliflozin and Metformin Combination oral administration of Empagliflozin and Metformin in fed condition	Drug	Sequence A, Sequence B

Primary outcome

AUC0-t
Time frame: 48 hour
AUC0-t of Metformin
Cmax
Time frame: 48 hour
Cmax of Metformin

5 secondary outcomes

Tmax
Time frame: 48 hour
AUCinf
Time frame: 48 hour
t1/2
Time frame: 48 hour
CL/F
Time frame: 48 hour
Vd/F
Time frame: 48 hour

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DW6014 in people with DW6014, 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 19 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 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?

Results are not available in the source record.

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 NCT05823883.

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.