HealthyPhase 1NCT07213310
Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults
A Phase 1 study testing DWP16001, DWC202511 and DWC202512 in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 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, DWC202511 and DWC202512
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Nov 2025to 7 Jan 2026
- 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.
- 50.0 kg ≤ Body weight ≤ 90.0 kg and 18.5 ≤ Body Mass Index (BMI) ≤ 29.9 kg/m² at the time of screening.
- Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study, etc.
Who cannot join
- Currect or history of clinically significant hepatic, renal, kidney, nervous, immune, respiratory, gastrointestinal, endocrine, hematologic/oncologic conditions, cardiovascular, genitourinary, psychiatric, or sexual disorders.
- History of gastrointestinal diseases (e.g., Crohn's disease, ulcers, gastritis, gastric spasms, gastroesophageal reflux disease) or surgeries (excluding simple appendectomy or hernia repair) that may affect the safety, pharmacokinetics, or pharmacodynamics of the investigational product.
- Current or history of gastrointestinal disorders or prior gastrointestinal surgery (except appendectomy or hernia repair) that may affect safety or PK/PD assessment of the investigational product.
- Current or history of urinary tract infection or genital fungal infection.
- Current or history of metabolic acidosis, such as diabetic ketoacidosis.
- Genetic disorders including galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jong No Gu, 03080
About this study
Official title: A Phase 1, Open-label, Fixed-sequence, Drug-drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 on the Pharmacokinetics of DWP16001 and Its Metabolite in Healthy Adult Subjects
Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults
Read the detailed description
A phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate the effect of DWC202511 or DWC202512 on the pharmacokinetics of DWP16001 and its metabolite in healthy adult subjects
- Conditions
- Healthy
- Being tested
- DWP16001, DWC202511, DWC202512
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP16001Drug
DWP16001 enavogliflozin (single oral dose) is administered in accordance with the study protocol.
DWC202511Drug
Repeated oral administration of DWC202511 500 mg twice daily (BID), in accordance with the study protocol.
DWC202512Drug
Repeated oral administration of DWC202512 once daily, in accordance with the study protocol
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Sequential administration of DWC202511, DWC202512, and DWP16001 | Experimental | Not described Receives: Drug: DWP16001; Drug: DWC202511; Drug: DWC202512 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: 1 week
AUClast
Measured: 1 week
Secondary outcomes (6)
AUCinf
AUCinf of DWP16001 and DWP16001 metabolites
Measured: 1 week
t1/2
t1/2 of DWP16001 and DWP16001 metabolites
Measured: 1 week
Tmax
Tmax of DWP16001 and DWP16001 metabolites
Measured: 1 week
CL/F
CL/F of DWP16001
Measured: 1 week
Vz/F
Vz/F of DWP16001
Measured: 1 week
metabolic ratio
metabolic ratio of DWP16001 metabolites
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start9 Nov 2025
- Primary completion7 Jan 2026
- Study completion7 Jan 2026
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
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
- NCT07213310
- Sponsor's protocol ID
- DW_DWP16001113
- Status last verified
- Feb 2026
- First submitted
- 29 Jul 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Fixed-sequence, Drug-drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 on the Pharmacokinetics of DWP16001 and Its Metabolite in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07213310
- Acronym / sponsor ID
- DW_DWP16001113
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2025 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 8 Oct 2025 (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.
Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults
Detailed description
A phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate the effect of DWC202511 or DWC202512 on the pharmacokinetics of DWP16001 and its metabolite in healthy adult subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Sequential administration of DWC202511, DWC202512, and DWP16001 | Experimental | Drug: DWP16001, Drug: DWC202511, Drug: DWC202512 |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult volunteers aged 19 to 50 years at the time of screening.
- 50.0 kg ≤ Body weight ≤ 90.0 kg and 18.5 ≤ Body Mass Index (BMI) ≤ 29.9 kg/m² at the time of screening.
- Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study, etc.
Key exclusion criteria (6 listed)
- Currect or history of clinically significant hepatic, renal, kidney, nervous, immune, respiratory, gastrointestinal, endocrine, hematologic/oncologic conditions, cardiovascular, genitourinary, psychiatric, or sexual disorders.
- History of gastrointestinal diseases (e.g., Crohn's disease, ulcers, gastritis, gastric spasms, gastroesophageal reflux disease) or surgeries (excluding simple appendectomy or hernia repair) that may affect the safety, pharmacokinetics, or pharmacodynamics of the investigational product.
- Current or history of gastrointestinal disorders or prior gastrointestinal surgery (except appendectomy or hernia repair) that may affect safety or PK/PD assessment of the investigational product.
- Current or history of urinary tract infection or genital fungal infection.
- Current or history of metabolic acidosis, such as diabetic ketoacidosis.
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 |
|---|---|---|
| DWP16001DWP16001 enavogliflozin (single oral dose) is administered in accordance with the study protocol. | Drug | Single Arm: Sequential administration of DWC202511, DWC202512, and DWP16001 |
| DWC202511Repeated oral administration of DWC202511 500 mg twice daily (BID), in accordance with the study protocol. | Drug | Single Arm: Sequential administration of DWC202511, DWC202512, and DWP16001 |
| DWC202512Repeated oral administration of DWC202512 once daily, in accordance with the study protocol | Drug | Single Arm: Sequential administration of DWC202511, DWC202512, and DWP16001 |
Primary outcome
Cmax
Time frame: 1 week
AUClast
Time frame: 1 week
6 secondary outcomes
AUCinf
Time frame: 1 week
t1/2
Time frame: 1 week
Tmax
Time frame: 1 week
CL/F
Time frame: 1 week
Vz/F
Time frame: 1 week
metabolic ratio
Time frame: 1 week
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 11 Feb 2026.
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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 DWP16001, DWC202511 and DWC202512 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 3 inclusion and 6 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 11 Feb 2026. 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?
Cmax (time frame: 1 week). 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 11 Feb 2026.