A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of HIP1601 40 mg in Healthy Volunteers

HM-ESOM-103

Primary objective - To evaluate food effect on the pharmacokinetics and the pharmacodynamics (PD) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition. Secondary objectives - To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.

2020-01-13

2020-02-20

2020-02-20

Completed

Early phase I

25

Inclusion Criteria: * Male/Female healthy volunteers in the age between 19 and 50 years old. * Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg. * Helicobacter pylori (H. Pylori) negative. * After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening. * Subject who are eligible from physical examination, clinical laboratory test by investigators judgment. Exclusion Criteria: * Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug. * Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to esomeprazole or the same component or other drugs (aspirin, antibiotics, etc.). * Blood serum aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization. * Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay. * Heavy smoker (\>10 cigarettes/day).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}

2022-11-01