Healthy SubjectPhase 1NCT05832697
An Exploratory Clinical Trial to Evaluate and Compare Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers
A Phase 1 study testing Ursodeoxycholic Acid 250 Mg Oral Tablet in people with Healthy Subject, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study aims to Evaluate and Compare Safety and Pharmacokinetic Characteristics after Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- Ursodeoxycholic Acid 250 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jan 2022to 30 Jan 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- 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 caffeine 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
Kyung Hee University Medical Hospital
Seoul, Korea, Republic of, 02447
About this study
This study aims to Evaluate and Compare Safety and Pharmacokinetic Characteristics after Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers.
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(DWC202108, DWC202109) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study
- Conditions
- Healthy Subject
- Being tested
- Ursodeoxycholic Acid 250 Mg Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic Acid 250 Mg Oral TabletDrug
Also called Ursodeoxycholic Acid 100 Mg Oral Tablet
Administration of Ursodeoxycholic Acid 250 Mg Oral Tablet or Ursodeoxycholic Acid 100 Mg Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | P1: DWJ1439(ursodeoxycholic acid) 100mg, P2: DWC202108(usrodeoxycholic acid) 250mg, P3: DWJ1464(ursodeoxycholic acid) 100mg Receives: Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet |
| Treatment B | Active comparator | P1: DWC202108(usrodeoxycholic acid) 250mg, P2: DWJ1439(ursodeoxycholic acid) 100mg, P3: DWC202109(ursodeoxycholic acid) 250mg Receives: Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet |
| Treatment C | Active comparator | P1: DWJ1464(ursodeoxycholic acid) 100mg, P2: DWC202109(ursodeoxycholic acid) 250mg, P3: DWJ1439(ursodeoxycholic acid) 100mg Receives: Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet |
| Treatment D | Active comparator | P1: DWC202109(ursodeoxycholic acid) 250mg, P2: DWJ1464(ursodeoxycholic acid) 100mg, P3: DWC202108(usrodeoxycholic acid) 250mg Receives: Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline corrected/uncorrected ursodeoxycholic acid AUC0-t
Baseline corrected/uncorrected ursodeoxycholic acid의 AUC0-t
Measured: -48 - 72hours
Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax
Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax
Measured: -48 - 72hours
Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t
Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t
Measured: -48 - 72hours
Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax
Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax
Measured: -48 - 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start27 Jan 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies 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
- Model description
- 4 by 3 cross-over study
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BoHyung Kim<bhkim98@gmail.com> Kim, MD, PhD, Principal investigator, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832697
- Sponsor's protocol ID
- DW_DWJ1464103
- Status last verified
- Apr 2023
- First submitted
- 2 Apr 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Trial to Evaluate and Compare Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05832697
- Acronym / sponsor ID
- DW_DWJ1464103
- Conditions
- Healthy Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 27 Apr 2023 (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 and Compare Safety and Pharmacokinetic Characteristics after Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers.
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(DWC202108, DWC202109) 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
- Model description
- 4 by 3 cross-over study
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: Ursodeoxycholic Acid 250 Mg Oral TabletP1: DWJ1439(ursodeoxycholic acid) 100mg, P2: DWC202108(usrodeoxycholic acid) 250mg, P3: DWJ1464(ursodeoxycholic acid) 100mg |
| Treatment B | Active comparator | Drug: Ursodeoxycholic Acid 250 Mg Oral TabletP1: DWC202108(usrodeoxycholic acid) 250mg, P2: DWJ1439(ursodeoxycholic acid) 100mg, P3: DWC202109(ursodeoxycholic acid) 250mg |
| Treatment C | Active comparator | Drug: Ursodeoxycholic Acid 250 Mg Oral TabletP1: DWJ1464(ursodeoxycholic acid) 100mg, P2: DWC202109(ursodeoxycholic acid) 250mg, P3: DWJ1439(ursodeoxycholic acid) 100mg |
| Treatment D | Active comparator | Drug: Ursodeoxycholic Acid 250 Mg Oral TabletP1: DWC202109(ursodeoxycholic acid) 250mg, P2: DWJ1464(ursodeoxycholic acid) 100mg, P3: DWC202108(usrodeoxycholic acid) 250mg |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 (4 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 caffeine 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 |
|---|---|---|
| Ursodeoxycholic Acid 250 Mg Oral TabletAlso: Ursodeoxycholic Acid 100 Mg Oral TabletAdministration of Ursodeoxycholic Acid 250 Mg Oral Tablet or Ursodeoxycholic Acid 100 Mg Oral Tablet | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
Primary outcome
Baseline corrected/uncorrected ursodeoxycholic acid AUC0-t
Time frame: -48 - 72hours
Baseline corrected/uncorrected ursodeoxycholic acid의 AUC0-t
Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax
Time frame: -48 - 72hours
Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax
Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t
Time frame: -48 - 72hours
Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t
Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax
Time frame: -48 - 72hours
Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax
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 27 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
BoHyung Kim<bhkim98@gmail.com> Kim, MD, PhD principal investigator
Kyung Hee University Hospital
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 Ursodeoxycholic Acid 250 Mg Oral Tablet in people with Healthy Subject, 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 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 27 Apr 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?
Baseline corrected/uncorrected ursodeoxycholic acid AUC0-t (time frame: -48 - 72hours). 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 27 Apr 2023.