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

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Jeil Pharmaceutical

Status and phase

Enrolling
Phase 1

Conditions

Healthy

Treatments

Drug: JLP-2004 qd

Study type

Interventional

Funder types

Industry

Identifiers

NCT06431399
JP-2004-102

Details and patient eligibility

About

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

36 estimated patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

36 participants in 2 patient groups

JLP-2004 FAST
Experimental group
Description:
Thin arm is JLP-2004 FAST condition
Treatment:
Drug: JLP-2004 qd
JLP-2004 FED
Experimental group
Description:
Thin arm is JLP-2004 FED condition
Treatment:
Drug: JLP-2004 qd

Trial contacts and locations

1

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Central trial contact

DAJIN KIM

Data sourced from clinicaltrials.gov

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