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Completed

NCT Number: NCT06171880

To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JC-001 and JLP-1901

To evaluate the safety and pharmacokinetic characteristics after the administration of JC-001 and JLP-1901

Completed

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Key information

Conditions

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bundang CHA university global clinical trials center Institutional Review Board

Gyeonggi-do, Bundang-gu, 13497, South Korea

About this study

An open-label, randomized, single administration, full replicated crossover phase 1 clinical trial to compare pharmacokinetics and safety between JLP-1901 and JC-001 in healthy subjects

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults over 19 years of age and under 65 years of age at the time of screening test
  • Those with a body mass index (BMI) of 17.5 kg/m2 or more but less than 30.5 kg/m2 and a body weight of 55 kg or more for men and 45 kg or more for women.
  • Those who do not have congenital or chronic diseases within the past 3 years and have no pathological symptoms or findings as a result of internal medical examination
  • Subjects determined to be suitable as a trial subject as a result of tests performed during screening, such as laboratory tests (hematology test, blood chemistry test, urinalysis, virus/bacteria test, etc.) conducted by the investigator according to the characteristics of the drug, vital signs, and electrocardiogram test.

Exclusion criteria

  • Those who have history or evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, nervous or immune diseases (excluding simple dental history such as calculus, impacted teeth, wisdom teeth, etc.)
  • Those whd have a history of gastrointestinal disease (esophageal disease such as achalasia or esophageal stricture, Crohn's disease) or surgery (excluding simple appendectomy, hernia surgery, or tooth extraction surgery) that may affect drug absorption ruler
  • A subject who shows the following values as a result of a laboratory test:

☞ ALT or AST > 2 times the upper limit of normal range

  • Those with a history of regular alcohol consumption exceeding 210 g/week within 6 months of screening (1 glass (250 mL) of beer (5%) = 10 g, 1 glass (50 mL) of soju (20%) = 8 g , 1 glass of wine (12%) (125 mL) = 12 g)

Treatment and study plan

JLP-1901

Drug

administration of JLP-1901

Other names: anti-viral

JC-001(active comparator)

Drug

administration of JC-001(tenofovir)

Other names: tenofovir

Primary outcomes

  1. AUC over 24H of JLP-1901

    Time frame: 24 hours

    AUC over 24H

  2. Cmax of JLP-1901

    Time frame: 24 hours

    Cmax

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Randomized, Single Administration, Full Replicated Crossover Phase 1 Clinical Trial to Compare Pharmacokinetics and Safety Between JLP-1901 and JC-001 in Healthy Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 15, 2023
Registry last updated
Dec 15, 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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