Clinical trial
A Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
Name
HM-ESOB-101
Description
A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
Trial arms
Trial start
2020-04-29
Estimated PCD
2020-10-30
Trial end
2020-10-30
Status
Completed
Phase
Early phase I
Treatment
HIP1802
Test drug
Arms:
Sequence 1, Sequence 2
HGP1705
Reference drug
Arms:
Sequence 1, Sequence 2
Size
49
Primary endpoint
AUClast
0-24hours
Reduced rate from baseline in 24h integrated gastric pH
0-24hours
Eligibility criteria
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).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 49, 'type': 'ACTUAL'}}
Updated at
2023-10-25
1 organization
2 products
1 indication
Organization
Hanmi PharmaceuticalProduct
HIP1802Indication
Healthy VolunteerProduct
HGP1705