None listed
Conditions
Interventions
Drug : product name : MotiReb Tab. 5/100 mg, Gasmotin 5 mg, Mucosta 100mg
The number of dosing : sing dosing
Route: oral administration
Wash-out period : 7 days
Sponsors
Ildong pharmaceutical
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Healthy male korean subjects age 20 to 45 at the screening visit 2)over 55kg with ideal body weight (BMI ? 20%) 3)Subject who has no congenital, chronic disease and disease symptoms in medical examination result. 4)Subject who is judged to be eligible according to clinical laboratory tests including hematological examination, blood chemistry examination, urine analysis. 5)Subject who volunteerly determined to participate in and agreed to comply with precautions after totally understand the detailed explanations about this study.
Exclusion criteria
Exclusion criteria: 1)Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, blood tumor, cardiovascular, urinary, endocrine system. 2)Subject who has history of surgical operation or diseases related to gastrointestinal symptom(e.g. crohn's disease, ulcer etc except appendectomy or simple for herina). 3)Subject who is hypersensitive to medicine containing component of mosapride, rebamipide or other medicine(asprin, antibiotics, etc.). 4)Subject who has hereditary problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc. 5)Subject who has one of following laboratory examination results. - AST or ALT > 1.5 times of upper limit of normal range - Total bilirubin > 1.5 times of upper limit of normal range 6)Subject who has hypertension or hypotonia, bradycardia or tachycardia in vital sign. 7)Subject who has medical history of use of drugs of abuse and/or tested positive findings on urinary drug screening. 8)Subject who takes drug metabolizing enzyme inducement or reducement drug such as barbiturates or takes food(grapefruit-containing juice)influence drug metabolism within 4 weeks before the first administration of the drug. 9)Subject who takes any ETC or oriental medicine within 3 weeks or takes any over-the-counter medication within 10 days(When other conditions is suitable for this study, according to the judgment of investigator, subject can participate in this study.) 10)Subject who has an experience in participating other clinical study within 3 months before the first administration. 11)Subject who donated whole blood within recent 2 months or donated components of blood within recent 1 month before initiation of this study 12)Subject who consistently intakes alcohol(>21 units/weeks, 1unit = 10g of pure alcohol)or can't stop drinking during the treatment period. 13)Subject who consistently smokes (> 10 cigarettes/day) or can't stop smoking during the treatment period. 14)Subject who estimated as an unsuitable subject for this study caused by clinical laboratory test and/or other reason by investigator. 15)Subject who can't use contraception during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt, Cmax of Rebamipide;AUCt, Cmax of Mosapride | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, T1/2, AUC8 of Rebamipide and Mosapride | — |
Countries
Korea, Republic of
Contacts
Public ContactHyun-Hui Kil
Inha University Hospital
Outcome results
None listed