Status:
COMPLETED
To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JT-001, JT-002 and JLP-2008
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
Conditions:
Healthy Adult
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06165965
Start Date
May 3 2022
End Date
June 27 2022
Last Update
December 12 2023
Active Locations (1)
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1
Bundang CHA university global clinical trials center Institutional Review Board
Gyeonggi-do, Bundang-gu, South Korea, 13497