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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Adult
• Intervention / Treatment: Drug: SGLT2 inhibitor

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; SGLT2 dual 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; SGLT2 dual inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC over24H of JLP-2008	24 hours
Cmax of JLP-2008	24 hours

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Actual): June 13, 2022
• Study Completion (Actual): June 27, 2022

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors
• Other Study ID Numbers: JP-2008-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No