Actively Recruiting
To Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004
Led by Jeil Pharmaceutical Co., Ltd. · Updated on 2024-05-28
36
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety, pharmacokinetic characteristics and the effect of food after administration of JLP-2004
CONDITIONS
Official Title
To Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult volunteers aged 19 years or older at the time of screening
- Weigh more than 50.0 kg and have a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2
- No congenital or chronic diseases and no pathological symptoms or findings upon medical examination
- Suitable clinical subjects based on laboratory tests, physical exams, and 12-lead electrocardiography
- Voluntarily agree in writing to participate and comply with study requirements after full understanding of the trial
You will not qualify if you...
- History or current medical conditions of significant liver, kidney, nervous system, mental, respiratory, endocrine, blood, tumor, genitourinary, cardiovascular, digestive, or musculoskeletal diseases
- Renal impairment or liver disorder
- Pregnant women or breastfeeding mothers
- Clinically significant hypersensitivity to Pelubiprofen, additives, aspirin, or other NSAIDs including COX-2 inhibitors
- Genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- History of gastrointestinal diseases (Crohn's disease, ulcer, pancreatitis) or gastrointestinal surgery affecting drug absorption (except simple appendectomy or hernia surgery)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chungbuk National University Hospital
Chungju, Seowon-gu, South Korea, 28644
Actively Recruiting
Research Team
D
DAJIN KIM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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