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

Phase 1

Completed

• Conditions: Heathy Volunteer
• Interventions: Drug: HIP1601 40mg

• Registration Number: NCT03882112
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-20
• Study Start: 2019-04-17
• Primary Completion: 2019-08-28
• Study Completion: 2019-08-28
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	HIP1601 40mg	Period 1: Fasted state + HIP1601 Period 2: Fed state + HIP1601
Sequence 2	HIP1601 40mg	Period 1: Fed state + HIP1601 Period 2: Fasted state + HIP1601

Primary Outcome Measures

Name	Time	Method
Cmax	Blood sampling during 24 hours after administration	Maximum observed concentration 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
t1/2	Blood sampling during 24 hours after administration	Terminal half-life
Vd/F	Blood sampling during 24 hours after administration	Apparent volume of distribution after extravascular administration, calculated as Dose/(λzㆍAUCinf)
Tmax	Blood sampling during 24 hours after administration	Time of Cmax over the time span specified
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
Clearance/F	Blood sampling during 24 hours after administration	Apparent total body clearance after extravascular administration, calculated as Dose/AUCinf

Trial Locations

Locations (1)

Seoul National University Biomedical Research Institute; 🇰🇷 Seoul, Korea, Republic of