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

Study Overview
=================
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

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

Conditions
-----------------
Overactive Bladder(OAB)

Intervention / Treatment
-----------------
* Drug: JLP-2002
* Drug: Comparator


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>Period I- comparator / Period II- comparator / Period III-JLP-2002 | Drug: JLP-2002<br>* administration of JLP-2002<br>Drug: Comparator<br>* administration of comparator<br>|
| Experimental: Group II<br>Period I- comparator / Period II- -JLP-2002 / Period III- comparator | Drug: JLP-2002<br>* administration of JLP-2002<br>Drug: Comparator<br>* administration of comparator<br>|
| Experimental: Group III<br>Period I- JLP-2002/ Period II- comparator / Period III- comparator | Drug: JLP-2002<br>* administration of JLP-2002<br>Drug: Comparator<br>* administration of comparator<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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