Healthy
Conditions
Keywords
pharmacokinetic
Brief summary
This study aims to evaluate the pharmacokinetics and the safety after administration of JLP-2302 and JP-1366 in healthy volunteers.
Interventions
DRUGJLP-2302
taking JLP-2302
DRUGJP-1366
taking JP-1366
Sponsors
Onconic Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects with a body mass index (BMI) between 18.0 and 30.0 kg/m² * Subjects without any clinically significant congenital or chronic disease, and with no pathological findings based on medical examination * Subjects who agree to use a medically acceptable method of contraception\*
Exclusion criteria
* Subjects who have taken enzyme-inducing or -inhibiting drugs * Subjects who have participated in a bioequivalence or other clinical trial and received an investigational product within 6 months prior to the first dose * Subjects with a history of gastrointestinal surgery that may affect drug absorption * Subjects with a clinically significant history of psychiatric illness * Female subjects who are pregnant, suspected of being pregnant, or currently breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma drug concentration-time curve(AUCt) | Pre-dose on Day 1 and on Days 2 post-dose |
| Peak Plasma Concentration (Cmax) | Pre-dose on Day 1 and on Days 2 post-dose |
Countries
South Korea
Outcome results
None listed