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

NCT ID: NCT06165965

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-03
• Study Completion Date: 2022-06-27

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 of JT-001, and JT-002 for healthy subjects in fasted state

Conditions

Healthy Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

SGLT2 inhibitor

Intervention Type: DRUG

SGLT2 dual inhibitor

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

Group Type: ACTIVE_COMPARATOR

SGLT2 inhibitor

Intervention Type: DRUG

SGLT2 dual inhibitor

Interventions

SGLT2 inhibitor

SGLT2 dual inhibitor

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bundang CHA university global clinical trials center Institutional Review Board

Gyeonggi-do, Bundang-gu, South Korea

Countries

South Korea

Other Identifiers

JP-2008-101

Identifier Type: -

Identifier Source: org_study_id