Healthy Adult
Conditions
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
Interventions
DRUGJLP-1901
administration of JLP-1901
DRUGJC-001(active comparator)
administration of JC-001(tenofovir)
Sponsors
Jeil Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults over 19 years of age and under 65 years of age at the time of screening test 2. 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. 3. 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 4. 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
1. 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.) 2. 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 3. 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 4. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC over 24H of JLP-1901 | 24 hours | AUC over 24H |
| Cmax of JLP-1901 | 24 hours | Cmax |
Countries
South Korea
Outcome results
None listed