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

Healthy Adult Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06165965
• Other study ID #: JP-2008-101
• Status: Completed
• Phase: Phase 1
• Start date: May 3, 2022
• Est. completion date: June 27, 2022

Study information

• Verified date: November 2023
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 27, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adult

Intervention

Drug:
• SGLT2 inhibitor
SGLT2 dual inhibitor

Locations

Country	Name	City	State
Korea, Republic of	Bundang CHA university global clinical trials center Institutional Review Board	Gyeonggi-do	Bundang-gu

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC over24H of JLP-2008		24 hours
Primary	Cmax of JLP-2008		24 hours