Healthy VolunteersPhase 1NCT05465668
Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of DWP16001 Drug A and C
A Phase 1 study testing DWP16001 Drug A and DWP16001 Drug C in people with Healthy Volunteers, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug C in healty 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 Volunteers
- What is being tested?
- DWP16001 Drug A and DWP16001 Drug C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jul 2022to 22 Nov 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
- 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
- ☞ BMI (kg/m2) = Body weight (kg) / {Height (m)}2
Who cannot join
- musculoskeletal diseases
- mental diseases
- hemato-oncologic diseases
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 DWP16001 Drug A and DWP16001 Drug C in Healthy Adult Volunteers
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug C in healty adult volunteers.
Read the detailed description
The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWP16001.
- Conditions
- Healthy Volunteers
- Being tested
- DWP16001 Drug A, DWP16001 Drug C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP16001 Drug ADrug
DWP16001 Drug A
DWP16001 Drug CDrug
DWP16001 Drug C
| Study group | Role | What they receive |
|---|---|---|
| Intervention: DWP16001 Drug A | Experimental | 1 tablet, Oral, once daily single dose Receives: Drug: DWP16001 Drug A |
| Intervention: DWP16001 Drug C | Experimental | 1 tablet, Oral, once daily single dose Receives: Drug: DWP16001 Drug C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss of DWP16001
Peak Plasma Concetration of DWP16001
Measured: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
AUClast of DWP16001
The area under the plasma drug concentration-time curve of DWP16001
Measured: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
Secondary outcomes (4)
Tmax of DWP16001
Time at Cmax of DWP16001
Measured: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
T1/2 of DWP16001
Half life of DWP16001
Measured: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
CL/F of DWP16001
Apparent total clearance of the drug from plasma after oral administration of DWP16001
Measured: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
Vd/F of DWP16001
Volume of distribution of DWP16001
Measured: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start22 Jul 2022
- Primary completion16 Aug 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 43 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
- NCT05465668
- Sponsor's protocol ID
- DW_DWP16001106
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2022
- Last updated
- 31 Jan 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 31 Jan 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 DWP16001 Drug A and DWP16001 Drug C in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05465668
- Acronym / sponsor ID
- DW_DWP16001106
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 20 Jul 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.
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug C in healty adult volunteers.
Detailed description
The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWP16001.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: DWP16001 Drug A | Experimental | Drug: DWP16001 Drug A1 tablet, Oral, once daily single dose |
| Intervention: DWP16001 Drug C | Experimental | Drug: DWP16001 Drug C1 tablet, Oral, once daily single dose |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
- ☞ BMI (kg/m2) = Body weight (kg) / {Height (m)}2
Key exclusion criteria (3 listed)
- musculoskeletal diseases
- mental diseases
- hemato-oncologic diseases
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 ADWP16001 Drug A | Drug | Intervention: DWP16001 Drug A |
| DWP16001 Drug CDWP16001 Drug C | Drug | Intervention: DWP16001 Drug C |
Primary outcome
Cmax,ss of DWP16001
Time frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
Peak Plasma Concetration of DWP16001
AUClast of DWP16001
Time frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
The area under the plasma drug concentration-time curve of DWP16001
4 secondary outcomes
Tmax of DWP16001
Time frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
T1/2 of DWP16001
Time frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
CL/F of DWP16001
Time frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
Vd/F of DWP16001
Time frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
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 31 Jan 2023.
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Screening Protocol
Pain
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 C in people with Healthy Volunteers, 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 2 inclusion and 3 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 31 Jan 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?
Cmax,ss of DWP16001 (time frame: At pre-dose (0 hour), and post-dose 0.25 to 72 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?
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 31 Jan 2023.