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

Healthy Adult Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06171880
• Other study ID #: JP-1901-102
• Status: Completed
• Phase: Phase 1
• Start date: February 15, 2022
• Est. completion date: May 13, 2022

Study information

• Verified date: November 2023
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 13, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Adult

Intervention

Drug:
• JLP-1901
administration of JLP-1901
• JC-001(active comparator)
administration of JC-001(tenofovir)

Locations

Country	Name	City	State
Korea, Republic of	Bundang CHA university global clinical trials center Institutional Review Board	Gyeonggi-do	Bundang-gu

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC over 24H of JLP-1901	AUC over 24H	24 hours
Primary	Cmax of JLP-1901	Cmax	24 hours