HealthyPhase 1NCT05414591
Pharmacokinetics and Safety Following Administration of DWP16001
A Phase 1 study testing DWP16001 drug A and DWP16001 drug B in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B in healthy adult volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DWP16001 drug A and DWP16001 drug B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2021to 1 Aug 2021
- 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 adult volunteers aged ≥ 19 years at screening
- Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
- Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination
- Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening.
Who cannot join
- Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
- Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
- Clinical laboratory test values are outside the accepted normal range at screening
- Other exclusive inclusion criteria, as defined in the protocol
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 13496
About this study
Official title: A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug B in Healthy Adult Volunteers
To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B in healthy adult volunteers
- Conditions
- Healthy
- Being tested
- DWP16001 drug A, DWP16001 drug B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP16001 drug ADrug
1 tablet, Oral, once daily single dose
DWP16001 drug BDrug
3 tablet, Oral, once daily single dose
| Study group | Role | What they receive |
|---|---|---|
| Sequence group A | Experimental | DWP16001 A mg 1T Receives: Drug: DWP16001 drug A; Drug: DWP16001 drug B |
| Sequence group B | Experimental | DWP16001 B mg 3T Receives: Drug: DWP16001 drug A; Drug: DWP16001 drug B |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0_t of DWP16001
Area under the plasma concentration versus time curve
Measured: 0-72 hours
Cmax of DWP16001
Peak Plasma Concetration
Measured: 0-72 hours
Secondary outcomes (5)
Tmax Tmax
Time at Cmax Tmax
Measured: 0-72 hours
AUC of DWP16001
Area under the plasma concentration versus time curve
Measured: 0-72 hours
T 1/2 of DWP16001
half life of DWP16001
Measured: 0-72 hours
CL/F of DWP16001
Apparent total clearance of the drug from plasma after oral administration
Measured: 0-72 hours
Vd/F of DWP16001
Volume of distribution
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 May 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
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
- 38 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
- NCT05414591
- Sponsor's protocol ID
- DW_DWP16001105
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 13 Jul 2022
- 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 13 Jul 2022. 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 DWP16001 Drug A and DWP16001 Drug B in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05414591
- Acronym / sponsor ID
- DW_DWP16001105
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 10 Jun 2022 (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.
To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B in healthy adult volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence group A | Experimental | Drug: DWP16001 drug A, Drug: DWP16001 drug BDWP16001 A mg 1T |
| Sequence group B | Experimental | Drug: DWP16001 drug A, Drug: DWP16001 drug BDWP16001 B mg 3T |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adult volunteers aged ≥ 19 years at screening
- Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
- Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination
- Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening.
Key exclusion criteria (4 listed)
- Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
- Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
- Clinical laboratory test values are outside the accepted normal range at screening
- Other exclusive inclusion criteria, as defined in the protocol
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 drug A1 tablet, Oral, once daily single dose | Drug | Sequence group A, Sequence group B |
| DWP16001 drug B3 tablet, Oral, once daily single dose | Drug | Sequence group A, Sequence group B |
Primary outcome
AUC0_t of DWP16001
Time frame: 0-72 hours
Area under the plasma concentration versus time curve
Cmax of DWP16001
Time frame: 0-72 hours
Peak Plasma Concetration
5 secondary outcomes
Tmax Tmax
Time frame: 0-72 hours
AUC of DWP16001
Time frame: 0-72 hours
T 1/2 of DWP16001
Time frame: 0-72 hours
CL/F of DWP16001
Time frame: 0-72 hours
Vd/F of DWP16001
Time frame: 0-72 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 13 Jul 2022.
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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 drug A and DWP16001 drug B 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 4 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 13 Jul 2022. 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 of DWP16001 (time frame: 0-72 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 13 Jul 2022.