Healthy AdultPhase 1NCT06169059
To Evaluate the Safety and Pharmacokinetic Characteristics After Multiple Administration of JC-013 and JLP-2004
A Phase 1 study testing JLP-2004 and JC-013 in people with Healthy Adult, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate the safety and pharmacokinetic characteristics after multiple administration of JC-013 and JLP-2004 Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- JLP-2004 and JC-013
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Oct 2023to 19 Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers aged 19 years or older at the time of screening
- At the time of screening, those who weigh more than 50.0 kg and have a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
- Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of internal medical examination (if necessary, electroencephalography, electrocardiogram, chest and stomach endoscopy, or gastrointestinal radiography)
- Those who be considered suitable for clinical subjects according to the results of laboratory tests (hematology tests, blood chemistry tests, urine tests, serum tests, blood coagulation tests, urine drugs tests), physical examinations and 12-lead electrocardiography at the time of screening
- Those who voluntarily decide to participate and agree in writing to comply with the subject compliance requirements during the clinical trial period after receiving a detailed explanation of this clinical trial and fully understanding it
Who cannot join
- Those who have current or past medical history of clinically significant liver, kidney, nervous system, mental, respiratory, endocrine, blood disease, tumor, genitourinary, cardiovascular, digestive, and musculoskeletal systems, as well as the following symptoms or history.
- ① Renal impairment
- ② Liver disorder
- For women, pregnant women (Urine-HCG positive) or breastfeeding mother
- Those who have clinically significant hypersensitivity reactions such as asthma, hives, allergies, etc. to the main ingredient (Pelubiprofen), additives, or other drugs (aspirin or other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors)) and have a history of hypersensitivity reaction
- Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Those with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs
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 Multiple Administration of JC-013 and JLP-2004 in Healthy Adult Volunteers
To evaluate the safety and pharmacokinetic characteristics after multiple administration of JC-013 and JLP-2004
Read the detailed description
A phase 1 clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after multiple administration of JC-013 and JLP-2004 in healthy adult volunteers
- Conditions
- Healthy Adult
- Being tested
- JLP-2004, JC-013
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JLP-2004Drug
administration of JLP-2004(COX-2 inhibitor)
JC-013Drug
administration of JC-013(COX-2 inhibitor))
| Study group | Role | What they receive |
|---|---|---|
| Treatment(Experimental): JLP-2004 | Experimental | Group I(Peroid I-comparator, Peroid II-JLP-2004), Group II(Period I-JLP-2004, Period II-Comparator) Receives: Drug: JLP-2004; Drug: JC-013 |
| Control(Active Comparator): JC-013 | Active comparator | Group I(Peroid I-comparator, Peroid II-JLP-2004), Group II(Period I-JLP-2004, Period II-Comparator) Receives: Drug: JLP-2004; Drug: JC-013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC last of JLP-2004
Measured: 24 hours
Cmax of JLP-2004
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start5 Oct 2023
- Primary completion8 Nov 2023
- Study completion19 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169059
- Sponsor's protocol ID
- JP-2004-101
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 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 Multiple Administration of JC-013 and JLP-2004 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06169059
- Acronym / sponsor ID
- JP-2004-101
- Conditions
- Healthy Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 19 Nov 2023 (actual)
- First posted
- 13 Dec 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.
To evaluate the safety and pharmacokinetic characteristics after multiple administration of JC-013 and JLP-2004
Detailed description
A phase 1 clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after multiple administration of JC-013 and JLP-2004 in healthy adult volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment(Experimental): JLP-2004 | Experimental | Drug: JLP-2004, Drug: JC-013Group I(Peroid I-comparator, Peroid II-JLP-2004), Group II(Period I-JLP-2004, Period II-Comparator) |
| Control(Active Comparator): JC-013 | Active comparator | Drug: JLP-2004, Drug: JC-013Group I(Peroid I-comparator, Peroid II-JLP-2004), Group II(Period I-JLP-2004, Period II-Comparator) |
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 or older at the time of screening
- At the time of screening, those who weigh more than 50.0 kg and have a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
- Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of internal medical examination (if necessary, electroencephalography, electrocardiogram, chest and stomach endoscopy, or gastrointestinal radiography)
- Those who be considered suitable for clinical subjects according to the results of laboratory tests (hematology tests, blood chemistry tests, urine tests, serum tests, blood coagulation tests, urine drugs tests), physical examinations and 12-lead electrocardiography at the time of screening
- Those who voluntarily decide to participate and agree in writing to comply with the subject compliance requirements during the clinical trial period after receiving a detailed explanation of this clinical trial and fully understanding it
Key exclusion criteria (7 listed)
- Those who have current or past medical history of clinically significant liver, kidney, nervous system, mental, respiratory, endocrine, blood disease, tumor, genitourinary, cardiovascular, digestive, and musculoskeletal systems, as well as the following symptoms or history.
- ① Renal impairment
- ② Liver disorder
- For women, pregnant women (Urine-HCG positive) or breastfeeding mother
- Those who have clinically significant hypersensitivity reactions such as asthma, hives, allergies, etc. to the main ingredient (Pelubiprofen), additives, or other drugs (aspirin or other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors)) and have a history of hypersensitivity reaction
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 |
|---|---|---|
| JLP-2004administration of JLP-2004(COX-2 inhibitor) | Drug | Control(Active Comparator): JC-013, Treatment(Experimental): JLP-2004 |
| JC-013administration of JC-013(COX-2 inhibitor)) | Drug | Control(Active Comparator): JC-013, Treatment(Experimental): JLP-2004 |
Primary outcome
AUC last of JLP-2004
Time frame: 24 hours
Cmax of JLP-2004
Time frame: 24 hours
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 13 Dec 2023.
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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.
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 JLP-2004 and JC-013 in people with Healthy Adult, run by Jeil 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 7 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 13 Dec 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?
AUC last of JLP-2004 (time frame: 24 hours). 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 13 Dec 2023.