Healthy Volunteer
Conditions
Brief summary
A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
Detailed description
A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
Interventions
DRUGHIP1802
Test drug
DRUGHGP1705
Reference drug
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 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast | 0-24hours |
| Reduced rate from baseline in 24h integrated gastric pH | 0-24hours |
Secondary
| Measure | Time frame |
|---|---|
| t1/2 | 0-24hours |
| CL/F | 0-24hours |
| Vd/F | 0-24hours |
| AUCtau | 0-24hours |
| Cmin,ss | 0-24hours |
| Cmax,ss | 0-24hours |
| Cmax | 0-24hours |
| CLss/F | 0-24hours |
| Vd,ss/F | 0-24hours |
| Reduced rate from baseline in 24h integrated gastric pH | 0-24hours |
| Duration time with integrated gastric pH>4 / 24hr | 0-24hours |
| Median 24 hr gastric pH | 0-24hours |
| t1/2,ss | 0-24hours |
| Tmax | 0-24hours |
Countries
South Korea
Outcome results
None listed