HealthyPhase 1DW_DWP16001112NCT06644404
Phase 1 Study of Drug-Drug Interactions Between DWP16001, DWC202407, and DWC202408 in Healthy Adults
A Phase 1 study testing DWP16001 0.3mg, DWC202407 1,000mg and DWC202408 2mg in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study aims to evaluate the pharmacokinetic/pharmacodynamic drug-drug interactions between DWP16001, DWC202407, and DWC202408 in healthy adults Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DWP16001 0.3mg, DWC202407 1,000mg and DWC202408 2mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Oct 2024to 1 Apr 2025
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers aged 19 to 50 years at the time of screening.
- Individuals with a body weight between 50.0 kg and 90.0 kg and a Body Mass Index (BMI) between 18.5 kg/m² and 29.9 kg/m² at the time of screening.
- Female volunteers must be neither pregnant nor breastfeeding, or must be in a surgically sterile state (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
- Individuals who have been fully informed about the clinical trial, have fully understood the details, voluntarily decided to participate, and provided written consent to comply with the precautions.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul
SeungHwan Lee, +82-2-550-8317, dayejung@daewoong.co.kr
About this study
Official title: A Randomized, Open, Two-sequence, Crossover, Multiple Oral Administrations, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Drug-drug Interaction Between DWP16001, DWC202407, and DWC202408 in Healthy Adults
This study aims to evaluate the pharmacokinetic/pharmacodynamic drug-drug interactions between DWP16001, DWC202407, and DWC202408 in healthy adults
Read the detailed description
This study aims to evaluate the pharmacokinetic interactions, pharmacodynamic interactions, safety, and tolerability of DWP16001, DWC202407, and DWC202408 in healthy adults
- Conditions
- Healthy
- Being tested
- DWP16001 0.3mg, DWC202407 1,000mg, DWC202408 2mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP16001 0.3mgDrug
1 tablet, Orally, Once daily single dose
DWC202407 1,000mgDrug
1 tablet, Orally, Twice daily
DWC202408 2mgDrug
1 tablet, Orally, Once daily single dose
| Study group | Role | What they receive |
|---|---|---|
| Enavogliflozin 0.3mg, once daily | Experimental | Not described Receives: Drug: DWP16001 0.3mg |
| Metformin 1,000mg, BID | Experimental | Not described Receives: Drug: DWC202407 1,000mg |
| Glimepiride 2mg, once daily | Experimental | Not described Receives: Drug: DWC202408 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss of DWP16001
Peak Plasma Concentration at steady-state
Measured: 0-24 hours
AUCtau,ss of DWP16001
Area under the plasma concentration versus time curve at Tau, steady-state
Measured: 0-24 hours
Cmax,ss of DWC202407
Peak Plasma Concentration at steady-state
Measured: 0-12 hours
AUCtau,ss of DWC202407
Area under the plasma concentration versus time curve at Tau, steady-state
Measured: 0-12 hours
Cmax,ss of DWC202408
Peak Plasma Concentration at steady-state
Measured: 0-24 hours
AUCtau,ss of DWC202408
Area under the plasma concentration versus time curve at Tau, steady-state
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start26 Oct 2024 (estimated)
- Primary completion3 Dec 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644404
- Sponsor's protocol ID
- DW_DWP16001112
- Acronym
- DW_DWP16001112
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 16 Oct 2024
- 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Two-sequence, Crossover, Multiple Oral Administrations, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Drug-drug Interaction Between DWP16001, DWC202407, and DWC202408 in Healthy Adults
- ClinicalTrials.gov ID
- NCT06644404
- Acronym / sponsor ID
- DW_DWP16001112 / DW_DWP16001112
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2024 (estimated)
- Primary completion
- 3 Dec 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 16 Oct 2024 (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 aims to evaluate the pharmacokinetic/pharmacodynamic drug-drug interactions between DWP16001, DWC202407, and DWC202408 in healthy adults
Detailed description
This study aims to evaluate the pharmacokinetic interactions, pharmacodynamic interactions, safety, and tolerability of DWP16001, DWC202407, and DWC202408 in healthy adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enavogliflozin 0.3mg, once daily | Experimental | Drug: DWP16001 0.3mg |
| Metformin 1,000mg, BID | Experimental | Drug: DWC202407 1,000mg |
| Glimepiride 2mg, once daily | Experimental | Drug: DWC202408 2mg |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult volunteers aged 19 to 50 years at the time of screening.
- Individuals with a body weight between 50.0 kg and 90.0 kg and a Body Mass Index (BMI) between 18.5 kg/m² and 29.9 kg/m² at the time of screening.
- Female volunteers must be neither pregnant nor breastfeeding, or must be in a surgically sterile state (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
- Individuals who have been fully informed about the clinical trial, have fully understood the details, voluntarily decided to participate, and provided written consent to comply with the precautions.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DWP16001 0.3mg1 tablet, Orally, Once daily single dose | Drug | Enavogliflozin 0.3mg, once daily |
| DWC202407 1,000mg1 tablet, Orally, Twice daily | Drug | Metformin 1,000mg, BID |
| DWC202408 2mg1 tablet, Orally, Once daily single dose | Drug | Glimepiride 2mg, once daily |
Primary outcome
Cmax,ss of DWP16001
Time frame: 0-24 hours
Peak Plasma Concentration at steady-state
AUCtau,ss of DWP16001
Time frame: 0-24 hours
Area under the plasma concentration versus time curve at Tau, steady-state
Cmax,ss of DWC202407
Time frame: 0-12 hours
Peak Plasma Concentration at steady-state
AUCtau,ss of DWC202407
Time frame: 0-12 hours
Area under the plasma concentration versus time curve at Tau, steady-state
Cmax,ss of DWC202408
Time frame: 0-24 hours
Peak Plasma Concentration at steady-state
AUCtau,ss of DWC202408
Time frame: 0-24 hours
Area under the plasma concentration versus time curve at Tau, steady-state
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- 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.
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 DWP16001 0.3mg, DWC202407 1,000mg and DWC202408 2mg in people with Healthy, run by Daewoong 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 4 inclusion and 0 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 16 Oct 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 DaYe Jung (+82-2-550-8317, dayejung@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax,ss of DWP16001 (time frame: 0-24 hours). The study lists 6 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 16 Oct 2024.