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
Overview
- Phase
- Phase 1
- Intervention
- JLP-2002
- Conditions
- Overactive Bladder(OAB)
- Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Cmax of JLP-2002
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Group I
Period I- comparator / Period II- comparator / Period III-JLP-2002
Intervention: JLP-2002
Group I
Period I- comparator / Period II- comparator / Period III-JLP-2002
Intervention: Comparator
Group II
Period I- comparator / Period II- -JLP-2002 / Period III- comparator
Intervention: JLP-2002
Group II
Period I- comparator / Period II- -JLP-2002 / Period III- comparator
Intervention: Comparator
Group III
Period I- JLP-2002/ Period II- comparator / Period III- comparator
Intervention: JLP-2002
Group III
Period I- JLP-2002/ Period II- comparator / Period III- comparator
Intervention: Comparator
Outcomes
Primary Outcomes
Cmax of JLP-2002
Time Frame: Time Frame: 192 hours
AUClast of JLP-2002
Time Frame: Time Frame: 192 hours