KCT0001123
Completed
未知
A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic Characteristics of Mosapride/Rebamipide Combination Tablet with Mosapride and Rebamipide Tablet in Healthy Male Korean Subjects
ConditionsDiseases of the digestive system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the digestive system
- Sponsor
- Ildong pharmaceutical
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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