Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers

Onconic Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JP-1366 20mg tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05712681

JP-1366-105

Details and patient eligibility

About

To Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral single dose of JP-1366 tablet in Healthy volunteers

Enrollment: 24 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Sequence 1

Experimental group

Description:

T → Washout period(7-14days) → R

Treatment:

Drug: JP-1366 20mg tablet

Drug: JP-1366 20mg tablet

Sequence 2

Experimental group

Description:

R → Washout period(7-14days) → T

Treatment:

Drug: JP-1366 20mg tablet

Drug: JP-1366 20mg tablet