Healthy
Conditions
Brief summary
To Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral single dose of JP-1366 tablet in Healthy volunteers
Interventions
T : JP-1366 20mg tablet after the meal
Sponsors
Onconic Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* A healthy adult aged between 19 and 45 years old * BMI between 18.0kg/m2 and 27.0kg/m2 at the time of screening
Exclusion criteria
* The subject who has clinically significant disease with liver, endocrine system, immune system, nervous system, kidney, cardiovascular disease, mental disorder, the blood of tumor disease, respiratory system or with history of the disease. * The subject who has a history of gastrointestinal disorders(e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or history of gastrointestinal surgery * The subject who has an allergic disease(excluding mild allergic rhinitis that does not require administration) or has a history of clinically significant hypersensitivity or adverse reactions to clinical trial drugs or drugs containing the same or other drugs (aspirin, NSAIDs, antibiotics, etc.). * The subject who has other clinically significant diseases or history * The subject who has a history of drug abuse * The subject who cannot withstand the insertion and maintenance of pH catheters
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of JP-1366 | Pre-dose(0 hour) and up to 34 hours in each period |
| AUClast of JP-1366 | Pre-dose(0 hour) and up to 34 hours in each period |
Secondary
| Measure | Time frame |
|---|---|
| Gastric pH | Pre-dose(0 hour) up to 24 hours after Investigational product administration |
Countries
South Korea
Outcome results
None listed