Healthy Adult Volunteer
Conditions
Brief summary
A Phase 1 Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers
Detailed description
A Randomized, Open-label, Multiple-dose, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics after Oral Administration of HIP2101 in Healthy Adult Volunteers
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers in the age between 19 and 50 years old. * Body mass index (BMI) in the range of 18 to 30 kg/m2 and weight 50.0kg 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 (Crohn's disease or Acute/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. * Aspartate aminotransferase and alanine aminotransferase exceed 2 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 6 months before the first administration or who cannot abstain from consent to post-study visit. * Heavy smoker (\>10 cigarettes/day).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration time with integrated gastric pH>4 / 24hr | 0-24hours |
Secondary
| Measure | Time frame |
|---|---|
| Median 24 hr gastric pH | 0-24hours |
| Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose | 0-24hours |
Countries
South Korea
Outcome results
None listed