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

NCT06169059 | Completed Phase 1

• 1 other identifier: JP-2004-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (2)

• AUC last of JLP-2004

  24 hours

• Cmax of JLP-2004

  24 hours

Study Arms (2)

Treatment(Experimental): JLP-2004

EXPERIMENTAL

Group I(Peroid I-comparator, Peroid II-JLP-2004), Group II(Period I-JLP-2004, Period II-Comparator)

Drug: JLP-2004; Drug: JC-013

Control(Active Comparator): JC-013

ACTIVE COMPARATOR

Group I(Peroid I-comparator, Peroid II-JLP-2004), Group II(Period I-JLP-2004, Period II-Comparator)

Drug: JLP-2004; Drug: JC-013

Interventions

JLP-2004 DRUG

administration of JLP-2004(COX-2 inhibitor)

Control(Active Comparator): JC-013; Treatment(Experimental): JLP-2004

JC-013 DRUG

administration of JC-013(COX-2 inhibitor))

Control(Active Comparator): JC-013; Treatment(Experimental): JLP-2004

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)

H plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

Location

Study Design

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

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 13, 2023
• Study Start: October 5, 2023
• Primary Completion: November 8, 2023
• Study Completion: November 19, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-11

Locations

KR (1)