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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04204629
• Other study ID #: HM-ESOM-103
• Status: Completed
• Phase: Phase 1
• Start date: January 13, 2020
• Est. completion date: February 20, 2020

Study information

• Verified date: February 2020
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• HIP1601 40mg
Single dosing of HIP1601 40mg, PO

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Biomedical Research Institute	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum observed concentration after dose	Blood sampling during 24 hours after administration
Primary	Area Under the plasma concentration versus time Curve(AUC)last	Area under the plasma concentration versus time curve from dosing to the last quantifiable concentration	Blood sampling during 24 hours after administration
Primary	Integrated gastric acidity for 24-hour	Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose	Blood sampling during 24 hours after administration
Secondary	Tmax	Time of Cmax over the time span specified	Blood sampling during 24 hours after administration
Secondary	AUCinf	Area under the plasma concentration versus time curve from the time of dosing to time extrapolated to infinitely	Blood sampling during 24 hours after administration
Secondary	t1/2	Terminal half-life	Blood sampling during 24 hours after administration
Secondary	Clearance/F	Apparent total body clearance after extravascular administration, calculated as Dose/AUCinf	Blood sampling during 24 hours after administration
Secondary	Vd/F	Apparent volume of distribution after extravascular administration, calculated as Dose/(?z?AUCinf)	Blood sampling during 24 hours after administration
Secondary	Duration of time intra-gastric pH 4.0 or higher	Percent of time with intra-gastric pH greater than 4.0 for 24-hour interval after dose	Blood sampling during 24 hours after administration
Secondary	Median pH	Median intra-gastric pH for 24-hour interval after dose	Blood sampling during 24 hours after administration