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CompletedNCT04914221Updated Jun 14, 2021

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

A Phase 1 interventional study of JLP-2002 and Comparator in Overactive Bladder(OAB), sponsored by Jeil Pharmaceutical Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-14.

Sponsored by Jeil Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study 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

Read the detailed description

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

02

Conditions studied

  • Overactive Bladder(OAB)
03

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 42 is below the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Jeil Pharmaceutical Co., Ltd. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Group I

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

    Drug: JLP-2002 · Drug: Comparator

  • Experimental
    Group II

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

    Drug: JLP-2002 · Drug: Comparator

  • Experimental
    Group III

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

    Drug: JLP-2002 · Drug: Comparator

Interventions

  • DrugJLP-2002

    administration of JLP-2002

  • DrugComparator

    administration of comparator

06

What researchers measure

Primary outcomes

  1. AUClast of JLP-2002

    Time frame: Time Frame: 192 hours

  2. Cmax of JLP-2002

    Time frame: Time Frame: 192 hours

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04914221
Lead sponsor
Jeil Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jun 4, 2021
Start date
Mar 13, 2021
Primary completion
May 26, 2021
Completion
May 26, 2021
Last update
Jun 14, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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