Clinical trial NCT03882112: Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heathy Volunteer
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2019-03-20
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary objective

- To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition.

Secondary objectives

* To explore food effect on the pharmacodynamics (PD) of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
* To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.


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).

Primary outcomes:
measure: Cmax
timeFrame: Blood sampling during 24 hours after administration
measure: Area Under the plasma concentration versus time Curve(AUC)last
timeFrame: Blood sampling during 24 hours after administration
Secondary outcomes:
measure: Tmax
timeFrame: Blood sampling during 24 hours after administration
measure: AUCinf
timeFrame: Blood sampling during 24 hours after administration
measure: t1/2
timeFrame: Blood sampling during 24 hours after administration
measure: Clearance/F
timeFrame: Blood sampling during 24 hours after administration
measure: Vd/F
timeFrame: Blood sampling during 24 hours after administration
Other outcomes:
measure: Integrated gastric acidity for 24-hour
timeFrame: Blood sampling during 24 hours after administration
measure: Duration of time intra-gastric pH 4.0 or higher
timeFrame: Blood sampling during 24 hours after administration
measure: Median pH
timeFrame: Blood sampling during 24 hours after administration
measure: Integrated gastric acidity by time interval
timeFrame: Blood sampling during 24 hours after administration
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Biomedical Research Institute
Study officials:
affiliation: Seoul National University Hospital, Seoul, Korea
name: Jang In-Jin, MD
role: PRINCIPAL_INVESTIGATOR
References: