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

Jeil Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Overactive Bladder(OAB)

Treatments: Drug: JLP-2002; Drug: Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT04914221

JLP-2002-101-PK

Details and patient eligibility

About

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

Full description

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

Enrollment: 42 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Group I

Experimental group

Description:

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

Treatment:

Drug: Comparator

Drug: JLP-2002

Group II

Experimental group

Description:

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

Treatment:

Drug: Comparator

Drug: JLP-2002

Group III

Experimental group

Description:

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

Treatment:

Drug: Comparator

Drug: JLP-2002