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CompletedNCT06165965Updated Dec 12, 2023

To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JT-001, JT-002 and JLP-2008

A Phase 1 interventional study of SGLT2 inhibitor in Healthy Adult, sponsored by Jeil Pharmaceutical Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by Jeil Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled May 2022, registered Nov 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Adult
03

In context

Lead sponsor

Jeil Pharmaceutical Co., Ltd. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy adults between 19 and 55 years of age at the time of screening test
  2. 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.
  3. 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

Exclusion criteria

Exclusion Criteria:

  1. Those with a clinically significant history of hypersensitivity, intolerance, or anaphylaxis to the main ingredient or other components of the investigational product
  2. 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.)
  3. 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
  4. 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Treatment(Experimental): JLP-2008

    - Group I(Peroid I-Comparator\[JT-001,JT-002\], Peroid II-JLP-2008), Group II(Period I-JLP-2008, Period II-Comparator\[JT-001,JT-002\])

    Drug: SGLT2 inhibitor

  • Active comparator
    Control(Active Comparator): JC-013

    - Group I(Peroid I-Comparator\[JT-001,JT-002\], Peroid II-JLP-2008), Group II(Period I-JLP-2008, Period II-Comparator\[JT-001,JT-002\])

    Drug: SGLT2 inhibitor

Interventions

  • DrugSGLT2 inhibitor

    SGLT2 dual inhibitor

06

What researchers measure

Primary outcomes

  1. AUC over24H of JLP-2008

    Time frame: 24 hours

  2. Cmax of JLP-2008

    Time frame: 24 hours

07

Study locations

1 site
  • Bundang CHA university global clinical trials center Institutional Review Board
    Gyeonggi-do, Bundang-gu 13497, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06165965
Lead sponsor
Jeil Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 12, 2023
Start date
May 3, 2022
Primary completion
Jun 13, 2022
Completion
Jun 27, 2022
Last update
Dec 12, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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