To Evaluate the Safety and Pharmacokinetic Characteristic... | NCT06169059

NCT06169059

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
JLP-2004	Drug	administration of JLP-2004(COX-2 inhibitor)	Control(Active Comparator): JC-013 Treatment(Experimental): JLP-2004

Measure	Description	Time Frame
AUC last of JLP-2004		24 hours
Cmax of JLP-2004		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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