Status:
COMPLETED
The Safety and PK Characteristics of the Co-administration of JLP-2002 and Comparator in Healthy Volunteers
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
Conditions:
Overactive Bladder(OAB)
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04914221
Start Date
March 13 2021
End Date
May 26 2021
Last Update
June 14 2021
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea