To Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004

Launched by JEIL PHARMACEUTICAL CO., LTD. · May 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called JLP-2004 to see how safe it is, how it behaves in the body, and how eating food might affect its effects. The trial is currently looking for healthy adult volunteers who are at least 19 years old, weigh more than 110 pounds, and have a body mass index (BMI) between 18 and 30. Participants should not have any significant health issues and must be in good health according to various medical tests.

If you decide to participate, you will undergo several medical assessments to ensure you meet the eligibility criteria. Throughout the trial, you will take the medication as directed and follow guidelines provided by the research team. It's important that you fully understand the trial and agree to participate voluntarily. This study is a great opportunity to contribute to medical research while also helping scientists learn more about this new treatment.

Gender

ALL

Eligibility criteria

• 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