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

NCT06431399 | Recruiting Phase 1

• 1 other identifier: JP-2004-102
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

JLP-2004 FAST

EXPERIMENTAL

Thin arm is JLP-2004 FAST condition

Drug: JLP-2004 qd

JLP-2004 FED

EXPERIMENTAL

Thin arm is JLP-2004 FED condition

Drug: JLP-2004 qd

Interventions

JLP-2004 qd DRUG

Group I(Peroid I-JLP-2004 FAST, Peroid II-JLP-2004 FED), Group II(Period I-JLP-2004 FED, Period II-JLP-2004 FAST)

Also known as: painkiller

JLP-2004 FAST; JLP-2004 FED

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult volunteers aged 19 years or older at the time of screening
• 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.
• 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)
• 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
• 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

You may not qualify if:

• 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
• For women, pregnant women (Urine-HCG positive) or breastfeeding mother
• 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
• Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• 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

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Chungbuk National University Hospital

Chungju, Seowon-gu, 28644, South Korea

RECRUITING

Study Officials

• Minkyu Park

  Chungbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DAJIN KIM

CONTACT

043-269-6781; cbnuhkimdajin@cbnuh.or.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: April 23, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 12, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)