Healthy AdultPhase 1NCT06165965
To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JT-001, JT-002 and JLP-2008
A Phase 1 study testing SGLT2 inhibitor 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 the administration of JT-001, JT-002 and JLP-2008 Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- SGLT2 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 May 2022to 27 Jun 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 adults between 19 and 55 years of age at the time of screening test
- At the time of the screening test, a subject weighing more than 50 kg for men and 45 kg for women, and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
- After receiving a detailed explanation of this clinical trial and fully understanding it, those who voluntarily decide to participate and give written consent before the screening procedure
Who cannot join
- Those with a clinically significant history of hypersensitivity, intolerance, or anaphylaxis to the main ingredient or other components of the investigational product
- Those who have clinically siginificant medical history of liver (severe liver disorders, etc.), kidneys (severe renal disorders, etc.), digestive system (pancreatitis, etc.), respiratory system, musculoskeletal system, endocrine system (diabetic ketoacidosis, diabetic coma and precoma, type 1 Diabetes mellitus), neuropsychiatric, hematologic/oncological, and cardiovascular (heart failure, orthostatic hypotension, etc.)
- Those with a history of Gastrointestinal disease (e.g. Crohn's disease, ulcerative disease, etc.) or surgery (excluding appendectomy, hernia surgery, endoscopic polyp surgery, hemorrhoids, dentition, and fistula surgery) that may affect the absorption of the investigational product
- Persons judged to be unsuitable as trial subjects in the test items conducted during screening
- Blood ALT, AST, Total bilirubin > 2 times the upper limit of normal range
- eGFR < 60 mL/min/1.73m2 (using CKD-EPI formula)
- HBsAg, HCV Ab, HIV, Syphilis regain test (RPR) results are positive
- Vital signs measured in the sitting position after resting for more than 3 minutes: systolic blood pressure > 160 mmHg or < 90 mmHg, or diastolic blood pressure > 100 mmHg or < 50 mmHg
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bundang CHA university global clinical trials center Institutional Review Board
Gyeonggi-do, Bundang-gu, 13497
About this study
Official title: A Randomized, Open-label, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of JLP-2008 and the Co-admin. of JT-001, and JT-002 for Healthy Subjects in Fasted State
To evaluate the safety and pharmacokinetic characteristics after the administration of JT-001, JT-002 and JLP-2008
Read the detailed description
A randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of JLP-2008 and the co-administration of JT-001, and JT-002 for healthy subjects in fasted state
- Conditions
- Healthy Adult
- Being tested
- SGLT2 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
SGLT2 dual inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Treatment(Experimental): JLP-2008 | Experimental | - Group I(Peroid I-Comparator[JT-001,JT-002], Peroid II-JLP-2008), Group II(Period I-JLP-2008, Period II-Comparator[JT-001,JT-002]) Receives: Drug: SGLT2 inhibitor |
| Control(Active Comparator): JC-013 | Active comparator | - Group I(Peroid I-Comparator[JT-001,JT-002], Peroid II-JLP-2008), Group II(Period I-JLP-2008, Period II-Comparator[JT-001,JT-002]) Receives: Drug: SGLT2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC over24H of JLP-2008
Measured: 24 hours
Cmax of JLP-2008
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 posted12 Dec 2023
- Study start3 May 2022
- Primary completion13 Jun 2022
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 48 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
- NCT06165965
- Sponsor's protocol ID
- JP-2008-101
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roh WL, Shin W, Yoo H, Ahn KH, Lee Y, Kim A. JLP-2008 Fixed-Dose Combination Tablet Demonstrates Bioequivalence and Comparable Safety to Separate Dapagliflozin + Pioglitazone in Healthy Participants. Eur J Drug Metab Pharmacokinet. 2026 Jun 10. doi: 10.1007/s13318-026-01014-0. Online ahead of print.
PubMed 42270920
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of JLP-2008 and the Co-admin. of JT-001, and JT-002 for Healthy Subjects in Fasted State
- ClinicalTrials.gov ID
- NCT06165965
- Acronym / sponsor ID
- JP-2008-101
- Conditions
- Healthy Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 May 2022 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 12 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 the administration of JT-001, JT-002 and JLP-2008
Detailed description
A randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of JLP-2008 and the co-administration of JT-001, and JT-002 for healthy subjects in fasted state
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-2008 | Experimental | Drug: SGLT2 inhibitor- Group I(Peroid I-Comparator[JT-001,JT-002], Peroid II-JLP-2008), Group II(Period I-JLP-2008, Period II-Comparator[JT-001,JT-002]) |
| Control(Active Comparator): JC-013 | Active comparator | Drug: SGLT2 inhibitor- Group I(Peroid I-Comparator[JT-001,JT-002], Peroid II-JLP-2008), Group II(Period I-JLP-2008, Period II-Comparator[JT-001,JT-002]) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults between 19 and 55 years of age at the time of screening test
- At the time of the screening test, a subject weighing more than 50 kg for men and 45 kg for women, and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
- After receiving a detailed explanation of this clinical trial and fully understanding it, those who voluntarily decide to participate and give written consent before the screening procedure
Key exclusion criteria (8 listed)
- Those with a clinically significant history of hypersensitivity, intolerance, or anaphylaxis to the main ingredient or other components of the investigational product
- Those who have clinically siginificant medical history of liver (severe liver disorders, etc.), kidneys (severe renal disorders, etc.), digestive system (pancreatitis, etc.), respiratory system, musculoskeletal system, endocrine system (diabetic ketoacidosis, diabetic coma and precoma, type 1 Diabetes mellitus), neuropsychiatric, hematologic/oncological, and cardiovascular (heart failure, orthostatic hypotension, etc.)
- Those with a history of Gastrointestinal disease (e.g. Crohn's disease, ulcerative disease, etc.) or surgery (excluding appendectomy, hernia surgery, endoscopic polyp surgery, hemorrhoids, dentition, and fistula surgery) that may affect the absorption of the investigational product
- Persons judged to be unsuitable as trial subjects in the test items conducted during screening
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 |
|---|---|---|
| SGLT2 inhibitorSGLT2 dual inhibitor | Drug | Control(Active Comparator): JC-013, Treatment(Experimental): JLP-2008 |
Primary outcome
AUC over24H of JLP-2008
Time frame: 24 hours
Cmax of JLP-2008
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 12 Dec 2023.
- Derived from this study: PubMed 42270920Roh WL, Shin W, Yoo H, Ahn KH, Lee Y, Kim A. JLP-2008 Fixed-Dose Combination Tablet Demonstrates Bioequivalence and Comparable Safety to Separate Dapagliflozin + Pioglitazone in Healthy Participants. Eur J Drug Metab Pharmacokinet. 2026 Jun 10. doi: 10.1007/s13318-026-01014-0. Online ahead of print.
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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 SGLT2 inhibitor 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 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 12 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 over24H of JLP-2008 (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?
On the ClinicalTrials.gov record for NCT06165965, which also lists 1 linked publication.
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 12 Dec 2023.