Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Subjects

Hanmi Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: HIP1601 40mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT04204629

HM-ESOM-103

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

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).