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

NCT04914221 | Completed Phase 1

• 1 other identifier: JLP-2002-101-PK
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Overactive Bladder(OAB)

Outcome Measures

Primary Outcomes (2)

• AUClast of JLP-2002

  Time Frame: 192 hours

• Cmax of JLP-2002

  Time Frame: 192 hours

Study Arms (3)

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

JLP-2002 DRUG

administration of JLP-2002

Group I; Group II; Group III

Comparator DRUG

administration of comparator

Group I; Group II; Group III

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 4, 2021
• Study Start: March 13, 2021
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: June 14, 2021

Record last verified: 2021-06

Locations

KR (1)