HealthyPhase 1NCT06754943
To Evaluate the Safety and PK Characteristics After Co-administration of JW0104 and C2402 and Administration of JW0105
A Phase 1 study testing Treatment A_Period 1, Treatment B_Period 2 and Treatment A_Period 3 in people with Healthy, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0104 and C2402 and administration of JW0105 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?
- Treatment A_Period 1, Treatment B_Period 2 and Treatment A_Period 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2025to 22 Apr 2025
- 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.
About this study
Official title: A Randomized, Open-label, Single Dose, 2x4 Replicate Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0104 and C2402 and Administration of JW0105 in Healthy Volunteers
The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0104 and C2402 and administration of JW0105 in healthy volunteers under fasting conditions.
Read the detailed description
Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
- Conditions
- Healthy
- Being tested
- Treatment A_Period 1, Treatment B_Period 2, Treatment A_Period 3, Treatment B_Period 4, Treatment B_Period 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A_Period 1Drug
Also called NA (Not Applicable)
- Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
- Wash-out period: 21 days
- Administration: Treatment A is administered orally with 150 mL of water under fasting conditions
Treatment B_Period 2Drug
Also called NA (Not Applicable)
- Administration alone of 1 tablet of JW0105
- Wash-out period: 21 days
- Administration: Treatment B is administered orally with 150 mL of water under fasting conditions
Treatment A_Period 3Drug
Also called NA (Not Applicable)
- Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
- Wash-out period: 21 days
- Administration: Treatment A is administered orally with 150 mL of water under fasting conditions
Treatment B_Period 4Drug
Also called NA (Not Applicable)
- Administration alone of 1 tablet of JW0105
- Wash-out period: 21 days
- Administration: Treatment B is administered orally with 150 mL of water under fasting conditions
Treatment B_Period 1Drug
Also called NA (Not Applicable)
- Administration alone of 1 tablet of JW0105
- Wash-out period: 21 days
- Administration: Treatment B is administered orally with 150 mL of water under fasting conditions
Treatment A_Period 2Drug
Also called NA (Not Applicable)
- Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
- Wash-out period: 21 days
- Administration: Treatment A is administered orally with 150 mL of water under fasting conditions
Treatment B_Period 3Drug
Also called NA (Not Applicable)
- Administration alone of 1 tablet of JW0105
- Wash-out period: 21 days
- Administration: Treatment B is administered orally with 150 mL of water under fasting conditions
Treatment A_Period 4Drug
Also called NA (Not Applicable)
- Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
- Wash-out period: 21 days
- Administration: Treatment A is administered orally with 150 mL of water under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | * Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
* Treatment B: Administration alone of 1 tablet of JW0105 Receives: Drug: Treatment A_Period 1; Drug: Treatment B_Period 2; Drug: Treatment A_Period 3; Drug: Treatment B_Period 4 |
| Group 2 | Other | * Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
* Treatment B: Administration alone of 1 tablet of JW0105 Receives: Drug: Treatment B_Period 1; Drug: Treatment A_Period 2; Drug: Treatment B_Period 3; Drug: Treatment A_Period 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Plasma concentrations are measured using a validated LC-MS/MS.
Measured: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4
Cmax
Plasma concentrations are measured using a validated LC-MS/MS.
Measured: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start17 Jan 2025
- Primary completion24 Mar 2025
- Study completion22 Apr 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung-Dae Kwon, Principal investigator, Metro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754943
- Sponsor's protocol ID
- JW24102
- Status last verified
- Sep 2025
- First submitted
- 10 Dec 2024
- Last updated
- 9 Sep 2025
- 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, 2x4 Replicate Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0104 and C2402 and Administration of JW0105 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06754943
- Acronym / sponsor ID
- JW24102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 1 Jan 2025 (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 objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0104 and C2402 and administration of JW0105 in healthy volunteers under fasting conditions.
Detailed description
Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: Treatment A_Period 1, Drug: Treatment B_Period 2, Drug: Treatment A_Period 3, Drug: Treatment B_Period 4* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105 |
| Group 2 | Other | Drug: Treatment B_Period 1, Drug: Treatment A_Period 2, Drug: Treatment B_Period 3, Drug: Treatment A_Period 4* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105 |
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 |
|---|---|---|
| Treatment A_Period 1Also: NA (Not Applicable)* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Wash-out period: 21 days * Administration: Treatment A is administered orally with 150 mL of water under fasting conditions | Drug | Group 1 |
| Treatment B_Period 2Also: NA (Not Applicable)* Administration alone of 1 tablet of JW0105 * Wash-out period: 21 days * Administration: Treatment B is administered orally with 150 mL of water under fasting conditions | Drug | Group 1 |
| Treatment A_Period 3Also: NA (Not Applicable)* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Wash-out period: 21 days * Administration: Treatment A is administered orally with 150 mL of water under fasting conditions | Drug | Group 1 |
| Treatment B_Period 4Also: NA (Not Applicable)* Administration alone of 1 tablet of JW0105 * Wash-out period: 21 days * Administration: Treatment B is administered orally with 150 mL of water under fasting conditions | Drug | Group 1 |
| Treatment B_Period 1Also: NA (Not Applicable)* Administration alone of 1 tablet of JW0105 * Wash-out period: 21 days * Administration: Treatment B is administered orally with 150 mL of water under fasting conditions | Drug | Group 2 |
| Treatment A_Period 2Also: NA (Not Applicable)* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Wash-out period: 21 days * Administration: Treatment A is administered orally with 150 mL of water under fasting conditions | Drug | Group 2 |
| Treatment B_Period 3Also: NA (Not Applicable)* Administration alone of 1 tablet of JW0105 * Wash-out period: 21 days * Administration: Treatment B is administered orally with 150 mL of water under fasting conditions | Drug | Group 2 |
| Treatment A_Period 4Also: NA (Not Applicable)* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Wash-out period: 21 days * Administration: Treatment A is administered orally with 150 mL of water under fasting conditions | Drug | Group 2 |
Primary outcome
AUCt
Time frame: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4
Plasma concentrations are measured using a validated LC-MS/MS.
Cmax
Time frame: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4
Plasma concentrations are measured using a validated LC-MS/MS.
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 9 Sep 2025.
- 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.
Sung-Dae Kwon principal investigator
Metro 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 Treatment A_Period 1, Treatment B_Period 2 and Treatment A_Period 3 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 9 Sep 2025. 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?
AUCt (time frame: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4). 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 9 Sep 2025.