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
Overview
- Phase
- Phase 1
- Intervention
- HIP1601 40mg
- Conditions
- Healthy Volunteer
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Cmax
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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).
Arms & Interventions
Sequence 1
Period 1: Fasted state + HIP1601 Period 2: Fed state + HIP1601
Intervention: HIP1601 40mg
Sequence 2
Period 1: Fed state + HIP1601 Period 2: Fasted state + HIP1601
Intervention: HIP1601 40mg
Outcomes
Primary Outcomes
Cmax
Time Frame: Blood sampling during 24 hours after administration
Maximum observed concentration after dose
Integrated gastric acidity for 24-hour
Time Frame: 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
Time Frame: Blood sampling during 24 hours after administration
Area under the plasma concentration versus time curve from dosing to the last quantifiable concentration
Secondary Outcomes
- Tmax(Blood sampling during 24 hours after administration)
- t1/2(Blood sampling during 24 hours after administration)
- Clearance/F(Blood sampling during 24 hours after administration)
- Median pH(Blood sampling during 24 hours after administration)
- Vd/F(Blood sampling during 24 hours after administration)
- Duration of time intra-gastric pH 4.0 or higher(Blood sampling during 24 hours after administration)
- AUCinf(Blood sampling during 24 hours after administration)