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The Safety and PK Characteristics of the Co-administration of JLP-2002 and Comparator in Healthy Volunteers

Primary Purpose

Overactive Bladder(OAB)

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
JLP-2002
Comparator
Sponsored by
Jeil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder(OAB)

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group I

Group II

Group III

Arm Description

Period I- comparator / Period II- comparator / Period III-JLP-2002

Period I- comparator / Period II- -JLP-2002 / Period III- comparator

Period I- JLP-2002/ Period II- comparator / Period III- comparator

Outcomes

Primary Outcome Measures

AUClast of JLP-2002
Cmax of JLP-2002

Secondary Outcome Measures

Full Information

First Posted
May 31, 2021
Last Updated
June 10, 2021
Sponsor
Jeil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04914221
Brief Title
The Safety and PK Characteristics of the Co-administration of JLP-2002 and Comparator in Healthy Volunteers
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 13, 2021 (Actual)
Primary Completion Date
May 26, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jeil Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
A randomized, open-label, single-dose, replicate crossover study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder(OAB)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
Period I- comparator / Period II- comparator / Period III-JLP-2002
Arm Title
Group II
Arm Type
Experimental
Arm Description
Period I- comparator / Period II- -JLP-2002 / Period III- comparator
Arm Title
Group III
Arm Type
Experimental
Arm Description
Period I- JLP-2002/ Period II- comparator / Period III- comparator
Intervention Type
Drug
Intervention Name(s)
JLP-2002
Intervention Description
administration of JLP-2002
Intervention Type
Drug
Intervention Name(s)
Comparator
Intervention Description
administration of comparator
Primary Outcome Measure Information:
Title
AUClast of JLP-2002
Time Frame
Time Frame: 192 hours
Title
Cmax of JLP-2002
Time Frame
Time Frame: 192 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

The Safety and PK Characteristics of the Co-administration of JLP-2002 and Comparator in Healthy Volunteers

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