Status:
COMPLETED
To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JC-001 and JLP-1901
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
Conditions:
Healthy Adult
Eligibility:
All Genders
19-65 years
Phase:
PHASE1
Brief Summary
To evaluate the safety and pharmacokinetic characteristics after the administration of JC-001 and JLP-1901
Detailed Description
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
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06171880
Start Date
February 15 2022
End Date
May 13 2022
Last Update
December 15 2023
Active Locations (1)
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1
Bundang CHA university global clinical trials center Institutional Review Board
Gyeonggi-do, Bundang-gu, South Korea, 13497