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

NCT ID: NCT04204629

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2020-02-20

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence 1

Period 1: Fasted state + HIP1601 Period 2: Fed state + HIP1601

Group Type: EXPERIMENTAL

HIP1601 40mg

Intervention Type: DRUG

Single dosing of HIP1601 40mg, PO

Sequence 2

Period 1: Fed state + HIP1601 Period 2: Fasted state + HIP1601

Group Type: EXPERIMENTAL

HIP1601 40mg

Intervention Type: DRUG

Single dosing of HIP1601 40mg, PO

Interventions

HIP1601 40mg

Single dosing of HIP1601 40mg, PO

Intervention Type: DRUG

Other Intervention Names

HIP1601

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).

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

In-Jin Jang, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital, Seoul, Korea

Locations

Seoul National University Biomedical Research Institute

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HM-ESOM-103

Identifier Type: -

Identifier Source: org_study_id