Erosive Esophagitis
Conditions
Brief summary
To compare the pharmacokinetics after administration of different formulation of CJ-12420
Detailed description
The purpose of this study is to compare the pharmacokinetics after a single dose administration of CJ-12420 formulation 1 and formulation 2.
Interventions
DRUGCJ-12420 formulation 2
CJ-12420 formulation 2
DRUGCJ-12420 formulation 1
CJ-12420 formulation 1
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male aged 19 to 45 years at the screening * Subject who is over 50kg with BMI between 19 kg/m2 to 28 kg/m2 (inclusive) * Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.
Exclusion criteria
* Subject who fall under the criteria below in laboratory test. * AST, ALT, ALP, GGT, total bilirubin, BUN, creatinine \> UNL x 1.5 * Subject who with low blood pressure with clinical significance at screening test. * (systolic blood pressure is less than 90 mmHg or over 140 mmHg, and diastolic blood pressure is less than 50 mmHg or over 90 mmHg) * Subject who has a medical history of symptomatic GERD, erosive esophagitis or duodenal ulcer, gastric ulcer, barrett's esophagus or zollinger-ellison syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the AUClast | Up to 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the AUCinf | Up to 48 hours |
| Tmax | Up to 48 hours |
| t1/2 | Up to 48 hours |
| Vd/F | Up to 48 hours |
Countries
South Korea
Outcome results
None listed