The Safety and PK Characteristics of the Co-administratio... | NCT04914221

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

NCT04914221

Sponsor

Jeil Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jun 14, 2021Actual

Enrollment

42Actual

Phase

Phase 1

Conditions

Overactive Bladder(OAB)

Interventions

JLP-2002
Comparator

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 13, 2021Actual

Primary Completion Date

May 26, 2021Actual

Completion Date

May 26, 2021Actual

First Submitted Date

May 31, 2021

First Submission Date that Met QC Criteria

May 31, 2021

First Posted Date

Jun 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2021

Last Update Posted Date

Jun 14, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I	Experimental	Period I- comparator / Period II- comparator / Period III-JLP-2002	Drug: JLP-2002 Drug: Comparator
Group II	Experimental	Period I- comparator / Period II- -JLP-2002 / Period III- comparator	Drug: JLP-2002 Drug: Comparator
Group III	Experimental	Period I- JLP-2002/ Period II- comparator / Period III- comparator	Drug: JLP-2002 Drug: Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JLP-2002	Drug	administration of JLP-2002	Group I Group II Group III

Measure	Description	Time Frame
AUClast of JLP-2002		Time Frame: 192 hours
Cmax of JLP-2002		Time Frame: 192 hours

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided