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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04914221

Enrollment

Registered

2021-06-04

Start date

2021-03-13

Completion date

2021-05-26

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder(OAB)

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

Interventions

DRUGJLP-2002

administration of JLP-2002

DRUGComparator

administration of comparator

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
AUClast of JLP-2002	Time Frame: 192 hours
Cmax of JLP-2002	Time Frame: 192 hours

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026