Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers

Hanmi Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: HGP1705

Drug: HIP1802

Study type

Interventional

Funder types

Industry

Identifiers

NCT04324905

HM-ESOB-101

Details and patient eligibility

About

A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers

Full description

A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers

Enrollment

49 patients

Sex

All

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.
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 investigational product or the same component or other drugs (aspirin, antibiotics, etc.).
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).