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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06431399
• Other study ID #: JP-2004-102
• Status: Recruiting
• Phase: Phase 1
• Start date: April 23, 2024
• Est. completion date: July 12, 2024

Study information

• Verified date: May 2024
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: DAJIN KIM
• Phone: 043-269-6781
• Email: cbnuhkimdajin[@]cbnuh.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: July 12, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

? Renal impairment

? 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

Related Conditions & MeSH terms

• Healthy

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Chungju	Seowon-gu

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of JLP-2004	AUCt of JLP-2004 in FAST and FED condition	after treatment 0hour, 0.5hour, 1hour, 2hour, 3hour, 24hour
Primary	Cmax of JLP-2004	Cmax of JLP-2004 in FAST and FED condition	after treatment 0hour, 0.5hour, 1hour, 2hour, 3hour, 24hour