HealthyPhase 1NCT05433844
To Evaluate the PK, PD, Safety and Drug Tolerance in Healthy Volunteers
A Phase 1 study testing Reference Drug or Test Drug in people with Healthy, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions 2. To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Reference Drug or Test Drug
- 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
- 2 Jun 2022to 14 Sep 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Subjects does not meet the Inclusion Criteria
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center, Seoul National University Hospital
Seoul
About this study
Official title: A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics of JW0301 to C2105 in Healthy Subjects
- To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
- To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
Read the detailed description
- It is analyzed for subjects who receive scheduled clinical trial drugs according to the clinical trial plan, have no significant violations in comparative analysis, and have completed all scheduled blood collection for pharmacokinetic evaluation. To analyze subjects who receive clinical trial medications scheduled according to the clinical trial plan, have no significant violations in comparative analysis, and have assessable intragastric pH information by completing a 24-h pH monitoring measurement.
- All subjects who received more than one dose of clinical trial drugs are evaluated.
- Conditions
- Healthy
- Being tested
- Reference Drug or Test Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference Drug or Test DrugDrug
Also called Reference Drug(C2105) or Test Drug(JW0301)
Test Drug: single administration of JW0301 Reference Drug: single administration of C2105
Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Test Drug for Period I Reference Drug for Period II Receives: Drug: Reference Drug or Test Drug |
| Group 2 | Other | Reference Drug for Period I Test Drug for Period II Receives: Drug: Reference Drug or Test Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
Evaluation PK for Esomeprazole after multiple dose
Measured: 0 ~ 24h
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose
Evaluation PD for ambulatory 24hr pH monitor
Measured: Baseline versus Multiple dose during 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start2 Jun 2022
- Primary completion26 Aug 2022
- Study completion14 Sep 2022
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A randomized, open, single-dose, 2x2 crossover-design clinical trial
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SeungHwan Lee, PI, Principal investigator, Clinical Trial Center, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433844
- Sponsor's protocol ID
- JW21103
- Status last verified
- Mar 2024
- First submitted
- 15 Jun 2022
- Last updated
- 21 Mar 2024
- Results posted
- 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 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics of JW0301 to C2105 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05433844
- Acronym / sponsor ID
- JW21103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 27 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 evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
- To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
Detailed description
- It is analyzed for subjects who receive scheduled clinical trial drugs according to the clinical trial plan, have no significant violations in comparative analysis, and have completed all scheduled blood collection for pharmacokinetic evaluation. To analyze subjects who receive clinical trial medications scheduled according to the clinical trial plan, have no significant violations in comparative analysis, and have assessable intragastric pH information by completing a 24-h pH monitoring measurement.
- All subjects who received more than one dose of clinical trial drugs are evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, open, single-dose, 2x2 crossover-design clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: Reference Drug or Test DrugTest Drug for Period I Reference Drug for Period II |
| Group 2 | Other | Drug: Reference Drug or Test DrugReference Drug for Period I Test Drug for Period II |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (1 listed)
- Subjects does not meet the Inclusion Criteria
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 |
|---|---|---|
| Reference Drug or Test DrugAlso: Reference Drug(C2105) or Test Drug(JW0301)Test Drug: single administration of JW0301 Reference Drug: single administration of C2105 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration | Drug | Group 1, Group 2 |
Primary outcome
AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
Time frame: 0 ~ 24h
Evaluation PK for Esomeprazole after multiple dose
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose
Time frame: Baseline versus Multiple dose during 7 days
Evaluation PD for ambulatory 24hr pH monitor
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 21 Mar 2024.
- 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.
SeungHwan Lee, PI principal investigator
Clinical Trial Center, Seoul National 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 Reference Drug or Test Drug in people with Healthy, run by JW Pharmaceutical 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 1 inclusion and 1 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 21 Mar 2024. 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?
AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state) (time frame: 0 ~ 24h). 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 21 Mar 2024.