- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04914221
The Safety and PK Characteristics of the Co-administration of JLP-2002 and Comparator in Healthy Volunteers
June 10, 2021 updated by: Jeil Pharmaceutical Co., Ltd.
A Randomized, Open-label, Single-dose, Replicate Crossover Study to Compare the Pharmacokinetics and Safety in Healthy Adult Volunteers Following Oral Administration of JLP-2002
A randomized, open-label, single-dose, replicate crossover study to compare the pharmacokinetics and safety in healthy adult volunteers following oral administration of JLP-2002
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized, open-label, single-dose, replicate crossover study
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Those who are 19 years of age or older and 55 years of age
- BMI 18.5 ~ 27.5 kg/m2
- Those who voluntarily agrees in writing after hearing a sufficient explanation of the purpose and procedure of the clinical trial
Exclusion Criteria:
- Those with clinically significant diseases or a history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, respiratory system, neuropsychiatric system, blood/oncology system, etc.
- Those with a history of gastrointestinal diseases or surgery that may affect the absorption of drugs
- Those who donated whole blood within 60 days from the date of eligibility assessment, or who donated component blood within 30 days
- Those who do not have a medically recognized contraceptive intention or plan to provide sperm from the screening date to 4 weeks from the last administration of the investigational drug
- Those whose blood AST, ALT, or GGT levels in the screening test exceeded 3 times the upper limit of the reference range
- Those who showed clinically significant results in the hepatitis B test, hepatitis C test, HIV test, and syphilis test
- In the case of women, those who do not show a negative response on the pregnancy test
- Those who judged that the investigator is not suitable for participation in clinical trials, such as showing clinically significant results in other screening tests
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I
Period I- comparator / Period II- comparator / Period III-JLP-2002
|
administration of JLP-2002
administration of comparator
|
Experimental: Group II
Period I- comparator / Period II- -JLP-2002 / Period III- comparator
|
administration of JLP-2002
administration of comparator
|
Experimental: Group III
Period I- JLP-2002/ Period II- comparator / Period III- comparator
|
administration of JLP-2002
administration of comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUClast of JLP-2002
Time Frame: Time Frame: 192 hours
|
Time Frame: 192 hours
|
Cmax of JLP-2002
Time Frame: Time Frame: 192 hours
|
Time Frame: 192 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2021
Primary Completion (Actual)
May 26, 2021
Study Completion (Actual)
May 26, 2021
Study Registration Dates
First Submitted
May 31, 2021
First Submitted That Met QC Criteria
May 31, 2021
First Posted (Actual)
June 4, 2021
Study Record Updates
Last Update Posted (Actual)
June 14, 2021
Last Update Submitted That Met QC Criteria
June 10, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JLP-2002-101-PK
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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