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

NCT06165965 | Completed Phase 1

• 1 other identifier: JP-2008-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and pharmacokinetic characteristics after the administration of JT-001, JT-002 and JLP-2008

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (2)

• AUC over24H of JLP-2008

  24 hours

• Cmax of JLP-2008

  24 hours

Study Arms (2)

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\[JT-001,JT-002\])

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\[JT-001,JT-002\])

Drug: SGLT2 inhibitor

Interventions

SGLT2 inhibitor DRUG

SGLT2 dual inhibitor

Control(Active Comparator): JC-013; Treatment(Experimental): JLP-2008

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Bundang CHA university global clinical trials center Institutional Review Board

Gyeonggi-do, Bundang-gu, 13497, South Korea

Location

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 12, 2023
• Study Start: May 3, 2022
• Primary Completion: June 13, 2022
• Study Completion: June 27, 2022
• Last Updated: December 12, 2023

Record last verified: 2023-11

Locations

KR (1)