Healthy Volunteers
Conditions
Brief summary
This is a randomized, open label, single dose, crossover study to evaluate the food effect on the pharmacokinetics after single oral dose of rebamipide SR 150 mg in healthy adult volunteers.
Interventions
DRUGRebamipide SR 150mg after high-fat meal
Test Drug
DRUGRebamipide SR 150mg under fasting condition
Reference Drug
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects who give consent to voluntary participation by signing the informed consent form 2. Healthy adult males aged ≥19 and ≤45 years at screening 3. Subjects with weight ≥50 kg AND body mass index (BMI) ≥18.0 and ≤27.0
Exclusion criteria
1. Subjects with hypersensitivity to the active ingredient of the IP or other anti-ulcer agents or history of clinically significant hypersensitivity 2. Subjects with any past history of gastrointestinal diseases which can affect the absorption of the IP 3. Subjects who have participated in other clinical trial and received any other investigational products within 6 months before the expected date of IP administration 4. Subjects who have taken any inducers or inhibitors of drug metabolism enzyme 5. Subjects who have been on diets that may affect the absorption, distribution, metabolism, and excretion of a drug 6. Subjects who donated whole blood within 2 months or underwent apheresis within 1 month prior to obtaining informed consent or who did not agree to prohibit blood donation 7. Smokers who have smoked \>10 cigarettes per day within the last 6 months 8. Subjects with any positive result on HBsAg, hepatitis C virus (HCV) Ab, HIV Ab, and (venereal disease research laboratory) VDRL tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | From Period1/ Day1 to Period2/Day9 | Peak Plasma Concentration of Rebamipide |
| AUClast of Rebamipide | From Period1/ Day1 to Period2/Day9 | Area Under the plasma concentration versus time curve last of Rebamipide |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 β of Rebamipide | From Period1/ Day1 to Period2/Day9 | Time taken for half the initial dose of Rebamipide administered to be eliminated from the body |
| Tmax of Rebamipide | From Period1/ Day1 to Period2/Day9 | Time at which the Cmax of Rebamipide is observed |
| AUCinf of Rebamipide | From Period1/ Day1 to Period2/Day9 | Area Under the plasma concentration versus time curve inifinite of Rebamipide |
Countries
South Korea
Outcome results
None listed