Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers
- Conditions
- Healthy
- Registration Number
- NCT05712681
- Lead Sponsor
- Onconic Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - A healthy adult aged between 19 and 45 years old<br><br> - BMI between 18.0kg/m2 and 27.0kg/m2 at the time of screening<br><br>Exclusion Criteria:<br><br> - The subject who has clinically significant disease with liver, endocrine system,<br> immune system, nervous system, kidney, cardiovascular disease, mental disorder, the<br> blood of tumor disease, respiratory system or with history of the disease.<br><br> - The subject who has a history of gastrointestinal disorders(e.g., gastroesophageal<br> reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease,<br> etc.) or history of gastrointestinal surgery<br><br> - The subject who has an allergic disease(excluding mild allergic rhinitis that does<br> not require administration) or has a history of clinically significant<br> hypersensitivity or adverse reactions to clinical trial drugs or drugs containing<br> the same or other drugs (aspirin, NSAIDs, antibiotics, etc.).<br><br> - The subject who has other clinically significant diseases or history<br><br> - The subject who has a history of drug abuse<br><br> - The subject who cannot withstand the insertion and maintenance of pH catheters
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax of JP-1366;AUClast of JP-1366
- Secondary Outcome Measures
Name Time Method Gastric pH