GERD
Conditions
Keywords
CKD-381
Brief summary
A study to investigate the effect of food on the Pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers
Detailed description
A randomized, open-label, single-dose, crossover study to investigate the effect of food on the pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers
Interventions
DRUGCKD-381
single-dose, oral administration of CKD-381 1 tablet
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Crossover Assignment
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Between 19 aged and 50 aged in healthy adult 2. Body weight more than 55.0kg and body mass index over 18.0kg/m2 and under 30.0kg/m2 3. Have negative result on Helicobacter Pylori antibody test
Exclusion criteria
1. Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease. 2. Have a gastrointestinal disease history(including surgery) that can effect evaluation of safety, pharmacokinetics and pharmacodynamics of investigational product. 3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product, additives or benzimidazole family.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0-24 hours | maximum observed concentration after dose |
| AUClast | 0-24 hours | Area under the plasma concentration versus time curve over the dosing interval after dose |
| Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose | 0-24 hours | — |
Countries
South Korea
Outcome results
None listed