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

Phase 1

Completed

• Conditions: Overactive Bladder(OAB)
• Interventions: Drug: JLP-2002; Drug: Comparator

• Registration Number: NCT04914221
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

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

Study Timeline

• Study Start: 2021-03-13
• Primary Completion: 2021-05-26
• Study Completion: 2021-05-26
• Study First Submitted: 2021-05-31
• Study First Submitted QC: 2021-05-31
• Status Verified: 2021-06
• Study First Posted: 2021-06-04
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group III	Comparator	Period I- JLP-2002/ Period II- comparator / Period III- comparator
Group II	Comparator	Period I- comparator / Period II- -JLP-2002 / Period III- comparator
Group I	Comparator	Period I- comparator / Period II- comparator / Period III-JLP-2002
Group I	JLP-2002	Period I- comparator / Period II- comparator / Period III-JLP-2002
Group III	JLP-2002	Period I- JLP-2002/ Period II- comparator / Period III- comparator
Group II	JLP-2002	Period I- comparator / Period II- -JLP-2002 / Period III- comparator

Primary Outcome Measures

Name	Time	Method
Cmax of JLP-2002	Time Frame: 192 hours
AUClast of JLP-2002	Time Frame: 192 hours

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of