Healthy SubjectsPhase 1NCT05874167
A Pharmacokinetic Study of DW6013 (FDC of Linagliptin and Metformin) in Healthy Adult Volunteers
A Phase 1 study testing DW6013 in people with Healthy Subjects, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6013 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?
- DW6013
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Aug 2022to 11 Oct 2022
- 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 and no more than 100 kg (inclusive) with a BMI between 18.5 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
- Pregnant subjects with a positive urine HCG test, or lactating female subjects
- Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals within 1 months prior to the first IP administration
- Subjects with clinically significant 12-lead ECG findings at the time of screening
- Subjects with a past history of drug abuse or a positive urine drug test
- Subjects with SBP ≥ 150 mmHg or ≤ 90 mmHg; DBP ≥ 100 mmHg or ≤ 60 mmHg; PR ≤ 40 bpm or ≥ 100 bpm at the time of screening
Show all 16Show fewer
- Subjects following an unusual diet or consumption of food which may affect the absorption, distribution, metabolism and excretion of the IP
- 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 who have participated and were given any other study drugs in other clinical study within 6 months prior to the first IP administration
- 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
- 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.
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 DW6013 and Loose Combination of Each Component in Healthy Adult Volunteers in Fast Condition
This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6013 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
- Conditions
- Healthy Subjects
- Being tested
- DW6013
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW6013Drug
Also called Linagliptin and Metformin
Drug: DW6013 Single oral administration of DW6013 after an overnight fast
Drug: Linagliptin and Metformin Single oral administration of Linagliptin and Metformin after an overnight fast
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1: Linagliptin and Metformin / Period 2: DW6013 Receives: Drug: DW6013 |
| Sequence B | Experimental | Period 1: DW6013 / Period 2: Linagliptin and Metformin Receives: Drug: DW6013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
AUC0-t of Linagliptin and Metformin
Measured: up to 72 hours
Cmax
Cmax of Linagliptin and Metformin
Measured: up to 72 hours
Secondary outcomes (6)
Tmax
Tmax of Linagliptin and Metformin
Measured: up to 72 hours
AUCinf
AUCinf of Linagliptin and Metformin
Measured: up to 72 hours
AUCextra
AUCextra of Linagliptin and Metformin
Measured: up to 72 hours
t1/2
t1/2 of Linagliptin and Metformin
Measured: up to 72 hours
CL/F
CL/F of Linagliptin and Metformin
Measured: up to 72 hours
Vd/F
Vd/F of Linagliptin and Metformin
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start8 Aug 2022
- Primary completion11 Oct 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874167
- Sponsor's protocol ID
- DW6013-I-1
- Status last verified
- May 2023
- First submitted
- 6 Apr 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 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 DW6013 and Loose Combination of Each Component in Healthy Adult Volunteers in Fast Condition
- ClinicalTrials.gov ID
- NCT05874167
- Acronym / sponsor ID
- DW6013-I-1
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 24 May 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 DW6013 and each component in healthy adult volunteers in fast 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: DW6013Period 1: Linagliptin and Metformin / Period 2: DW6013 |
| Sequence B | Experimental | Drug: DW6013Period 1: DW6013 / Period 2: Linagliptin 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 and no more than 100 kg (inclusive) with a BMI between 18.5 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 (16 listed)
- Subjects with any clinically significant hepatic, renal, nervous, respiratory, endocrine, circulatory, tumor, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases or other medical history
- Pregnant subjects with a positive urine HCG test, or lactating female subjects
- Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals within 1 months prior to the first IP administration
- Subjects with clinically significant 12-lead ECG findings at the time of screening
- Subjects with a past history of drug abuse or a positive urine drug test
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 |
|---|---|---|
| DW6013Also: Linagliptin and MetforminDrug: DW6013 Single oral administration of DW6013 after an overnight fast Drug: Linagliptin and Metformin Single oral administration of Linagliptin and Metformin after an overnight fast | Drug | Sequence A, Sequence B |
Primary outcome
AUC0-t
Time frame: up to 72 hours
AUC0-t of Linagliptin and Metformin
Cmax
Time frame: up to 72 hours
Cmax of Linagliptin and Metformin
6 secondary outcomes
Tmax
Time frame: up to 72 hours
AUCinf
Time frame: up to 72 hours
AUCextra
Time frame: up to 72 hours
t1/2
Time frame: up to 72 hours
CL/F
Time frame: up to 72 hours
Vd/F
Time frame: up to 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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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 DW6013 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 16 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 24 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: up to 72 hours). 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?
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 24 May 2023.