To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JC-001 and JLP-1901

Phase 1

Completed

• Conditions: Healthy Adult
• Interventions: Drug: JLP-1901; Drug: JC-001(active comparator)

• Registration Number: NCT06171880
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

Brief Summary

To evaluate the safety and pharmacokinetic characteristics after the administration of JC-001 and JLP-1901

Detailed Description

An open-label, randomized, single administration, full replicated crossover phase 1 clinical trial to compare pharmacokinetics and safety between JLP-1901 and JC-001 in healthy subjects

Study Timeline

• Study Start: 2022-02-15
• Primary Completion: 2022-03-11
• Study Completion: 2022-05-13
• Status Verified: 2023-11
• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-15
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Healthy adults over 19 years of age and under 65 years of age at the time of screening test
2. Those with a body mass index (BMI) of 17.5 kg/m2 or more but less than 30.5 kg/m2 and a body weight of 55 kg or more for men and 45 kg or more for women.
3. Those who do not have congenital or chronic diseases within the past 3 years and have no pathological symptoms or findings as a result of internal medical examination
4. Subjects determined to be suitable as a trial subject as a result of tests performed during screening, such as laboratory tests (hematology test, blood chemistry test, urinalysis, virus/bacteria test, etc.) conducted by the investigator according to the characteristics of the drug, vital signs, and electrocardiogram test.

Exclusion Criteria

1. Those who have history or evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, nervous or immune diseases (excluding simple dental history such as calculus, impacted teeth, wisdom teeth, etc.)

2. Those whd have a history of gastrointestinal disease (esophageal disease such as achalasia or esophageal stricture, Crohn's disease) or surgery (excluding simple appendectomy, hernia surgery, or tooth extraction surgery) that may affect drug absorption ruler

3. A subject who shows the following values as a result of a laboratory test:

   ☞ ALT or AST > 2 times the upper limit of normal range

4. Those with a history of regular alcohol consumption exceeding 210 g/week within 6 months of screening (1 glass (250 mL) of beer (5%) = 10 g, 1 glass (50 mL) of soju (20%) = 8 g , 1 glass of wine (12%) (125 mL) = 12 g)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment(Experimental): JLP-1901	JC-001(active comparator)	Group I(Peroid I-Comparator\[JLP-2008\], Peroid II-Treatment\[JC-001\], Period III-Comparator\[JLP-2008\], Peroid IV-Treatment\[JC-001\]), Group II(Peroid I-Treatment\[JC-001\]Comparator\[JLP-2008\], Peroid II-Comparator\[JLP-2008\], Period III-Treatment\[JC-001\], Peroid IV-Comparator\[JLP-2008\])
Control(Active Comparator): JC-001	JLP-1901	Group I(Peroid I-Comparator\[JLP-2008\], Peroid II-Treatment\[JC-001\], Period III-Comparator\[JLP-2008\], Peroid IV-Treatment\[JC-001\]), Group II(Peroid I-Treatment\[JC-001\]Comparator\[JLP-2008\], Peroid II-Comparator\[JLP-2008\], Period III-Treatment\[JC-001\], Peroid IV-Comparator\[JLP-2008\])
Control(Active Comparator): JC-001	JC-001(active comparator)	Group I(Peroid I-Comparator\[JLP-2008\], Peroid II-Treatment\[JC-001\], Period III-Comparator\[JLP-2008\], Peroid IV-Treatment\[JC-001\]), Group II(Peroid I-Treatment\[JC-001\]Comparator\[JLP-2008\], Peroid II-Comparator\[JLP-2008\], Period III-Treatment\[JC-001\], Peroid IV-Comparator\[JLP-2008\])
Treatment(Experimental): JLP-1901	JLP-1901	Group I(Peroid I-Comparator\[JLP-2008\], Peroid II-Treatment\[JC-001\], Period III-Comparator\[JLP-2008\], Peroid IV-Treatment\[JC-001\]), Group II(Peroid I-Treatment\[JC-001\]Comparator\[JLP-2008\], Peroid II-Comparator\[JLP-2008\], Period III-Treatment\[JC-001\], Peroid IV-Comparator\[JLP-2008\])

Primary Outcome Measures

Name	Time	Method
Cmax of JLP-1901	24 hours	Cmax
AUC over 24H of JLP-1901	24 hours	AUC over 24H

Trial Locations

Locations (1)

Bundang CHA university global clinical trials center Institutional Review Board; 🇰🇷 Gyeonggi-do, Bundang-gu, Korea, Republic of