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To evaluate the safety, pharmacokinetic characteristics and the effect of food after administration of JLP-2004
Full 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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups
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Central trial contact
DAJIN KIM
Data sourced from clinicaltrials.gov
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