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

Sponsor

Jeil Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04914221

Collaborator

(none)

Enrollment

Location

Arms

2.4

Actual Duration (Months)

17.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder(OAB)	Drug: JLP-2002 Drug: Comparator	Phase 1

Detailed Description

A randomized, open-label, single-dose, replicate crossover study

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 13, 2021

Actual Primary Completion Date :

May 26, 2021

Actual Study Completion Date :

May 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I Period I- comparator / Period II- comparator / Period III-JLP-2002	Drug: JLP-2002 administration of JLP-2002 Drug: Comparator administration of comparator
Experimental: Group II Period I- comparator / Period II- -JLP-2002 / Period III- comparator	Drug: JLP-2002 administration of JLP-2002 Drug: Comparator administration of comparator
Experimental: Group III Period I- JLP-2002/ Period II- comparator / Period III- comparator	Drug: JLP-2002 administration of JLP-2002 Drug: Comparator administration of comparator

Arm

Intervention/Treatment

Experimental: Group I

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

Drug: JLP-2002

administration of JLP-2002

Drug: Comparator

administration of comparator

Experimental: Group II

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

Drug: JLP-2002

administration of JLP-2002

Drug: Comparator

administration of comparator

Experimental: Group III

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

Drug: JLP-2002

administration of JLP-2002

Drug: Comparator

administration of comparator

Outcome Measures

Primary Outcome Measures

AUClast of JLP-2002 [Time Frame: 192 hours]
Cmax of JLP-2002 [Time Frame: 192 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Jeil Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeil Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04914221

Other Study ID Numbers:

JLP-2002-101-PK

First Posted:

Jun 4, 2021

Last Update Posted:

Jun 14, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Bladder, Overactive

Study Results

No Results Posted as of Jun 14, 2021