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

Phase 1

Completed

• Conditions: Healthy Adult
• Interventions: Drug: JLP-2004; Drug: JC-013

• Registration Number: NCT06169059
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2023-10-05
• Status Verified: 2023-11
• Primary Completion: 2023-11-08
• Study Completion: 2023-11-19
• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-12-10
• Last Update Submitted: 2023-12-10
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control(Active Comparator): JC-013	JLP-2004	Group I(Peroid I-comparator, Peroid II-JLP-2004), Group II(Period I-JLP-2004, Period II-Comparator)
Control(Active Comparator): JC-013	JC-013	Group I(Peroid I-comparator, Peroid II-JLP-2004), Group II(Period I-JLP-2004, Period II-Comparator)
Treatment(Experimental): JLP-2004	JLP-2004	Group I(Peroid I-comparator, Peroid II-JLP-2004), Group II(Period I-JLP-2004, Period II-Comparator)
Treatment(Experimental): JLP-2004	JC-013	Group I(Peroid I-comparator, Peroid II-JLP-2004), Group II(Period I-JLP-2004, Period II-Comparator)

Primary Outcome Measures

Name	Time	Method
AUC last of JLP-2004	24 hours
Cmax of JLP-2004	24 hours

Trial Locations

Locations (1)

H plus Yangji Hospital; 🇰🇷 Seoul, Gwanak-gu, Korea, Republic of