Overactive Bladder(OAB)Phase 1NCT04914221
The Safety and PK Characteristics of the Co-administration of JLP-2002 and Comparator in Healthy Volunteers
A Phase 1 study testing JLP-2002 and Comparator in people with Overactive Bladder(OAB), run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A randomized, open-label, single-dose, replicate crossover study to compare the pharmacokinetics and safety in healthy adult volunteers following oral administration of JLP-2002 Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder(OAB)
- What is being tested?
- JLP-2002 and Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Mar 2021to 26 May 2021
- 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
- Those who are 19 years of age or older and 55 years of age
- BMI 18.5 ~ 27.5 kg/m2
- Those who voluntarily agrees in writing after hearing a sufficient explanation of the purpose and procedure of the clinical trial
Who cannot join
- Those with clinically significant diseases or a history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, respiratory system, neuropsychiatric system, blood/oncology system, etc.
- Those with a history of gastrointestinal diseases or surgery that may affect the absorption of drugs
- Those who donated whole blood within 60 days from the date of eligibility assessment, or who donated component blood within 30 days
- Those who do not have a medically recognized contraceptive intention or plan to provide sperm from the screening date to 4 weeks from the last administration of the investigational drug
- Those whose blood AST, ALT, or GGT levels in the screening test exceeded 3 times the upper limit of the reference range
- Those who showed clinically significant results in the hepatitis B test, hepatitis C test, HIV test, and syphilis test
- In the case of women, those who do not show a negative response on the pregnancy test
- Those who judged that the investigator is not suitable for participation in clinical trials, such as showing clinically significant results in other screening tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dose, Replicate Crossover Study to Compare the Pharmacokinetics and Safety in Healthy Adult Volunteers Following Oral Administration of JLP-2002
A randomized, open-label, single-dose, replicate crossover study to compare the pharmacokinetics and safety in healthy adult volunteers following oral administration of JLP-2002
Read the detailed description
A randomized, open-label, single-dose, replicate crossover study
- Conditions
- Overactive Bladder(OAB)
- Being tested
- JLP-2002, Comparator
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JLP-2002Drug
administration of JLP-2002
ComparatorDrug
administration of comparator
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Period I- comparator / Period II- comparator / Period III-JLP-2002 Receives: Drug: JLP-2002; Drug: Comparator |
| Group II | Experimental | Period I- comparator / Period II- -JLP-2002 / Period III- comparator Receives: Drug: JLP-2002; Drug: Comparator |
| Group III | Experimental | Period I- JLP-2002/ Period II- comparator / Period III- comparator Receives: Drug: JLP-2002; Drug: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of JLP-2002
Measured: Time Frame: 192 hours
Cmax of JLP-2002
Measured: Time Frame: 192 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start13 Mar 2021
- Primary completion26 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder(OAB)Studies 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
- 42 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
- NCT04914221
- Sponsor's protocol ID
- JLP-2002-101-PK
- Status last verified
- Jun 2021
- First submitted
- 31 May 2021
- Last updated
- 14 Jun 2021
- 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 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Replicate Crossover Study to Compare the Pharmacokinetics and Safety in Healthy Adult Volunteers Following Oral Administration of JLP-2002
- ClinicalTrials.gov ID
- NCT04914221
- Acronym / sponsor ID
- JLP-2002-101-PK
- Conditions
- Overactive Bladder(OAB)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2021 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 4 Jun 2021 (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.
A randomized, open-label, single-dose, replicate crossover study to compare the pharmacokinetics and safety in healthy adult volunteers following oral administration of JLP-2002
Detailed description
A randomized, open-label, single-dose, replicate crossover study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: JLP-2002, Drug: ComparatorPeriod I- comparator / Period II- comparator / Period III-JLP-2002 |
| Group II | Experimental | Drug: JLP-2002, Drug: ComparatorPeriod I- comparator / Period II- -JLP-2002 / Period III- comparator |
| Group III | Experimental | Drug: JLP-2002, Drug: ComparatorPeriod I- JLP-2002/ Period II- comparator / Period III- comparator |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Those who are 19 years of age or older and 55 years of age
- BMI 18.5 ~ 27.5 kg/m2
- Those who voluntarily agrees in writing after hearing a sufficient explanation of the purpose and procedure of the clinical trial
Key exclusion criteria (8 listed)
- Those with clinically significant diseases or a history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, respiratory system, neuropsychiatric system, blood/oncology system, etc.
- Those with a history of gastrointestinal diseases or surgery that may affect the absorption of drugs
- Those who donated whole blood within 60 days from the date of eligibility assessment, or who donated component blood within 30 days
- Those who do not have a medically recognized contraceptive intention or plan to provide sperm from the screening date to 4 weeks from the last administration of the investigational drug
- Those whose blood AST, ALT, or GGT levels in the screening test exceeded 3 times the upper limit of the reference range
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-2002administration of JLP-2002 | Drug | Group I, Group II, Group III |
| Comparatoradministration of comparator | Drug | Group I, Group II, Group III |
Primary outcome
AUClast of JLP-2002
Time frame: Time Frame: 192 hours
Cmax of JLP-2002
Time frame: Time Frame: 192 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 14 Jun 2021.
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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-2002 and Comparator in people with Overactive Bladder(OAB), 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 3 inclusion and 8 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 14 Jun 2021. 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?
AUClast of JLP-2002 (time frame: Time Frame: 192 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 14 Jun 2021.