Prospective study in comparing the safety and the pharmacokinetics of Mosapride and Rebamipide having the effects on gastrointestinal diseases when administered as single drug or a complex in healthy korean male adults
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0001123
- Lead Sponsor
- Ildong pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 30
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.
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCt, Cmax of Rebamipide;AUCt, Cmax of Mosapride
- Secondary Outcome Measures
Name Time Method Tmax, T1/2, AUC8 of Rebamipide and Mosapride