HealthyPhase 1NCT04477369
Safety and Pharmacokinetics of DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Volunteers
A Phase 1 study testing DWJ1439, DWJ1464 and DWC202003 in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults. 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?
- DWJ1439, DWJ1464 and DWC202003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Aug 2020to Sep 2020
- 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 old to under 55.
- BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg
- Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination.
- Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG).
- Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.
Who cannot join
- Known history or presence of any clinically significant medical condition.
- Participation in a clinical drug study or bioequivalence study 6 months prior to the present study.
- Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period.
- Refusal to abstain from alcohol, caffeine, or other xanthines, or grapefruit containing food or drinks for 72 hours before drug administration and during each study period.
- Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Medical Hospital
Seoul
Bo-Hyung Kim
About this study
Official title: An Exploratory Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Adult Volunteers
The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults.
Read the detailed description
The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study
- Conditions
- Healthy
- Being tested
- DWJ1439, DWJ1464, DWC202003, DWC202004
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1439Drug
300mg single dose
DWJ1464Drug
300mg single dose
DWC202003Drug
300mg single dose
DWC202004Drug
300mg single dose
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Other | 7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3. Receives: Drug: DWJ1439; Drug: DWJ1464; Drug: DWC202003 |
| Sequence B | Other | 7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3. Receives: Drug: DWJ1464; Drug: DWC202003; Drug: DWC202004 |
| Sequence C | Other | 7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3. Receives: Drug: DWJ1439; Drug: DWC202003; Drug: DWC202004 |
| Sequence D | Other | 7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3. Receives: Drug: DWJ1439; Drug: DWJ1464; Drug: DWC202004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t
Area under the plasma concentration-time curve from time 0 to time t
Measured: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax
Maximum plasma drug concentration
Measured: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUC0-t
Area under the plasma concentration-time curve from time 0 to time t
Measured: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cmax
Maximum plasma drug concentration
Measured: 0 - 72 hours after dosing
Secondary outcomes (10)
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUCinf
Area under the plasma concentration-time curve from drug administration to drug elimination
Measured: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax
Time to reach maximum plasma concentration following drug administration
Measured: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: t1/2
Elimination half-life
Measured: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: , Cl/F
Apparent total clearance of drug from plasma after oral administration
Measured: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F
Apparent volume of distribution after oral administration
Measured: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUCinf
Area under the plasma concentration-time curve from drug administration to drug elimination
Measured: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Tmax
Time to reach maximum plasma concentration following drug administration
Measured: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: t1/2
Elimination half-life
Measured: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cl/F
Apparent total clearance of drug from plasma after oral administration
Measured: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Vd/F
Apparent volume of distribution after oral administration
Measured: 0 - 72 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start6 Aug 2020 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completionSep 2020 (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
- 28 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
- NCT04477369
- Sponsor's protocol ID
- DW_DWJ1464101
- Status last verified
- Jul 2020
- First submitted
- 22 Jun 2020
- Last updated
- 29 Jul 2020
- 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 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04477369
- Acronym / sponsor ID
- DW_DWJ1464101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2020 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 20 Jul 2020 (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.
The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults.
Detailed description
The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Other | Drug: DWJ1439, Drug: DWJ1464, Drug: DWC2020037 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3. |
| Sequence B | Other | Drug: DWJ1464, Drug: DWC202003, Drug: DWC2020047 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3. |
| Sequence C | Other | Drug: DWJ1439, Drug: DWC202003, Drug: DWC2020047 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3. |
| Sequence D | Other | Drug: DWJ1439, Drug: DWJ1464, Drug: DWC2020047 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adult volunteers aged 19 years old to under 55.
- BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg
- Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination.
- Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG).
- Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.
Key exclusion criteria (5 listed)
- Known history or presence of any clinically significant medical condition.
- Participation in a clinical drug study or bioequivalence study 6 months prior to the present study.
- Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period.
- Refusal to abstain from alcohol, caffeine, or other xanthines, or grapefruit containing food or drinks for 72 hours before drug administration and during each study period.
- Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.
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 |
|---|---|---|
| DWJ1439300mg single dose | Drug | Sequence A, Sequence C, Sequence D |
| DWJ1464300mg single dose | Drug | Sequence A, Sequence B, Sequence D |
| DWC202003300mg single dose | Drug | Sequence A, Sequence B, Sequence C |
| DWC202004300mg single dose | Drug | Sequence B, Sequence C, Sequence D |
Primary outcome
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t
Time frame: 0 - 72 hours after dosing
Area under the plasma concentration-time curve from time 0 to time t
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax
Time frame: 0 - 72 hours after dosing
Maximum plasma drug concentration
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUC0-t
Time frame: 0 - 72 hours after dosing
Area under the plasma concentration-time curve from time 0 to time t
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cmax
Time frame: 0 - 72 hours after dosing
Maximum plasma drug concentration
10 secondary outcomes
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUCinf
Time frame: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax
Time frame: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: t1/2
Time frame: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: , Cl/F
Time frame: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F
Time frame: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUCinf
Time frame: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Tmax
Time frame: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: t1/2
Time frame: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cl/F
Time frame: 0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Vd/F
Time frame: 0 - 72 hours after dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- 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 DWJ1439, DWJ1464 and DWC202003 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 5 inclusion and 5 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 29 Jul 2020. 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 Bo-Hyung Kim (+82-2-958-9326, bhkim98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t (time frame: 0 - 72 hours after dosing). The study lists 4 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 29 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.