MedDataX Logo

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

NCT ID: NCT06171880

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2022-05-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Adult

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment(Experimental): JLP-1901

Group I(Peroid I-Comparator\[JLP-2008\], Peroid II-Treatment\[JC-001\], Period III-Comparator\[JLP-2008\], Peroid IV-Treatment\[JC-001\]), Group II(Peroid I-Treatment\[JC-001\]Comparator\[JLP-2008\], Peroid II-Comparator\[JLP-2008\], Period III-Treatment\[JC-001\], Peroid IV-Comparator\[JLP-2008\])

Group Type EXPERIMENTAL

JLP-1901

Intervention Type DRUG

administration of JLP-1901

JC-001(active comparator)

Intervention Type DRUG

administration of JC-001(tenofovir)

Control(Active Comparator): JC-001

Group I(Peroid I-Comparator\[JLP-2008\], Peroid II-Treatment\[JC-001\], Period III-Comparator\[JLP-2008\], Peroid IV-Treatment\[JC-001\]), Group II(Peroid I-Treatment\[JC-001\]Comparator\[JLP-2008\], Peroid II-Comparator\[JLP-2008\], Period III-Treatment\[JC-001\], Peroid IV-Comparator\[JLP-2008\])

Group Type ACTIVE_COMPARATOR

JLP-1901

Intervention Type DRUG

administration of JLP-1901

JC-001(active comparator)

Intervention Type DRUG

administration of JC-001(tenofovir)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

JLP-1901

administration of JLP-1901

Intervention Type DRUG

JC-001(active comparator)

administration of JC-001(tenofovir)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

anti-viral tenofovir

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bundang CHA university global clinical trials center Institutional Review Board

Gyeonggi-do, Bundang-gu, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JP-1901-102

Identifier Type: -

Identifier Source: org_study_id