Healthy
Conditions
Brief summary
To evaluate the safety, pharmacokinetic characteristics and the effect of food after administration of JLP-2004
Detailed 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
Interventions
DRUGJLP-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)
Sponsors
Jeil Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt of JLP-2004 | after treatment 0hour, 0.5hour, 1hour, 2hour, 3hour, 24hour | AUCt of JLP-2004 in FAST and FED condition |
| Cmax of JLP-2004 | after treatment 0hour, 0.5hour, 1hour, 2hour, 3hour, 24hour | Cmax of JLP-2004 in FAST and FED condition |
Countries
South Korea
Contacts
Primary ContactDAJIN KIM
Outcome results
None listed