To Evaluate the Safety and Pharmacokinetic Characteristics After Multiple Administration of JC-013 and JLP-2004

A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Multiple Administration of JC-013 and JLP-2004 in Healthy Adult Volunteers

To evaluate the safety and pharmacokinetic characteristics after multiple administration of JC-013 and JLP-2004

Study Overview

• Status: Completed
• Conditions: Healthy Adult
• Intervention / Treatment: Drug: JLP-2004; Drug: JC-013

Detailed Description

A phase 1 clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after multiple administration of JC-013 and JLP-2004 in healthy adult volunteers

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwanak-gu
    • Seoul, Gwanak-gu, Korea, Republic of, 08779
      • H Plus Yangji Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Healthy adult volunteers aged 19 years or older at the time of screening
2. At the time of screening, those who weigh more than 50.0 kg and have a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
3. Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of internal medical examination (if necessary, electroencephalography, electrocardiogram, chest and stomach endoscopy, or gastrointestinal radiography)
4. Those who be considered suitable for clinical subjects according to the results of laboratory tests (hematology tests, blood chemistry tests, urine tests, serum tests, blood coagulation tests, urine drugs tests), physical examinations and 12-lead electrocardiography at the time of screening
5. Those who voluntarily decide to participate and agree in writing to comply with the subject compliance requirements during the clinical trial period after receiving a detailed explanation of this clinical trial and fully understanding it

Exclusion Criteria:

1. Those who have current or past medical history of clinically significant liver, kidney, nervous system, mental, respiratory, endocrine, blood disease, tumor, genitourinary, cardiovascular, digestive, and musculoskeletal systems, as well as the following symptoms or history.

   ① Renal impairment

   ② Liver disorder

2. For women, pregnant women (Urine-HCG positive) or breastfeeding mother
3. Those who have clinically significant hypersensitivity reactions such as asthma, hives, allergies, etc. to the main ingredient (Pelubiprofen), additives, or other drugs (aspirin or other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors)) and have a history of hypersensitivity reaction
4. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
5. Those with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs

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-2004; Group I(Peroid I-comparator, Peroid II-JLP-2004), Group II(Period I-JLP-2004, Period II-Comparator)	Drug: JLP-2004; administration of JLP-2004(COX-2 inhibitor); Drug: JC-013; administration of JC-013(COX-2 inhibitor))
Active Comparator: Control(Active Comparator): JC-013; Group I(Peroid I-comparator, Peroid II-JLP-2004), Group II(Period I-JLP-2004, Period II-Comparator)	Drug: JLP-2004; administration of JLP-2004(COX-2 inhibitor); Drug: JC-013; administration of JC-013(COX-2 inhibitor))

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC last of JLP-2004	24 hours
Cmax of JLP-2004	24 hours

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Actual): November 8, 2023
• Study Completion (Actual): November 19, 2023

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: December 10, 2023
• First Posted (Estimated): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: JP-2004-101

Drug and device information, study documents

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