Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Subjects
- Conditions
- Healthy Volunteer
- Interventions
- Drug: HIP1601 40mg
- Registration Number
- NCT04204629
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 2 HIP1601 40mg Period 1: Fed state + HIP1601 Period 2: Fasted state + HIP1601 Sequence 1 HIP1601 40mg Period 1: Fasted state + HIP1601 Period 2: Fed state + HIP1601
- Primary Outcome Measures
Name Time Method Cmax Blood sampling during 24 hours after administration Maximum observed concentration after dose
Integrated gastric acidity for 24-hour Blood sampling during 24 hours after administration Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose
Area Under the plasma concentration versus time Curve(AUC)last Blood sampling during 24 hours after administration Area under the plasma concentration versus time curve from dosing to the last quantifiable concentration
- Secondary Outcome Measures
Name Time Method Tmax Blood sampling during 24 hours after administration Time of Cmax over the time span specified
t1/2 Blood sampling during 24 hours after administration Terminal half-life
Clearance/F Blood sampling during 24 hours after administration Apparent total body clearance after extravascular administration, calculated as Dose/AUCinf
Median pH Blood sampling during 24 hours after administration Median intra-gastric pH for 24-hour interval after dose
Vd/F Blood sampling during 24 hours after administration Apparent volume of distribution after extravascular administration, calculated as Dose/(λzㆍAUCinf)
Duration of time intra-gastric pH 4.0 or higher Blood sampling during 24 hours after administration Percent of time with intra-gastric pH greater than 4.0 for 24-hour interval after dose
AUCinf Blood sampling during 24 hours after administration Area under the plasma concentration versus time curve from the time of dosing to time extrapolated to infinitely
Trial Locations
- Locations (1)
Seoul National University Biomedical Research Institute
🇰🇷Seoul, Korea, Republic of