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Completed

NCT Number: NCT06169059

To Evaluate the Safety and Pharmacokinetic Characteristics After Multiple Administration of JC-013 and JLP-2004

To evaluate the safety and pharmacokinetic characteristics after multiple administration of JC-013 and JLP-2004

Completed

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

About this study

A phase 1 clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after multiple administration of JC-013 and JLP-2004 in healthy adult volunteers

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult volunteers aged 19 years or older at the time of screening
  • 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.
  • 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)
  • 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
  • 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

  • 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

Treatment and study plan

JLP-2004

Drug

administration of JLP-2004(COX-2 inhibitor)

JC-013

Drug

administration of JC-013(COX-2 inhibitor))

Primary outcomes

  1. AUC last of JLP-2004

    Time frame: 24 hours

  2. Cmax of JLP-2004

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Multiple Administration of JC-013 and JLP-2004 in Healthy Adult Volunteers

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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