To Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004

A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004 in Healthy Adult Volunteers

To evaluate the safety, pharmacokinetic characteristics and the effect of food after administration of JLP-2004

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: JLP-2004 qd

Detailed Description

A randomized, open-label, crossover phase 1 clinical trial to evaluate the safety, pharmacokinetic characteristics and the effect of food after administration of JLP-2004 in healthy adult volunteers

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: DAJIN KIM; Phone Number: 043-269-6781; Email: cbnuhkimdajin@cbnuh.or.kr

Study Locations

• Korea, Republic of
  • Seowon-gu
    • Chungju, Seowon-gu, Korea, Republic of, 28644
      • Recruiting
      • Chungbuk National University Hospital
      • Contact: DAJIN KIM; Phone Number: 043-269-6781; Email: cbnuhkimdajin@cbnuh.or.kr

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: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JLP-2004 FAST; Thin arm is JLP-2004 FAST condition	Drug: JLP-2004 qd; Group I(Peroid I-JLP-2004 FAST, Peroid II-JLP-2004 FED), Group II(Period I-JLP-2004 FED, Period II-JLP-2004 FAST); Other Names: painkiller
Experimental: JLP-2004 FED; Thin arm is JLP-2004 FED condition	Drug: JLP-2004 qd; Group I(Peroid I-JLP-2004 FAST, Peroid II-JLP-2004 FED), Group II(Period I-JLP-2004 FED, Period II-JLP-2004 FAST); Other Names: painkiller

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of JLP-2004	AUCt of JLP-2004 in FAST and FED condition	after treatment 0hour, 0.5hour, 1hour, 2hour, 3hour, 24hour
Cmax of JLP-2004	Cmax of JLP-2004 in FAST and FED condition	after treatment 0hour, 0.5hour, 1hour, 2hour, 3hour, 24hour

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Minkyu Park, Chungbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 12, 2024

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 27, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: JP-2004-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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