A Randomized, Open-Label, Single-dosing and Cross-over Clinical Trial to Investigate the Safety and Pharmacokinetic Drug-Drug Interaction of YH4808 and Diclofenac in Healthy Male Volunteers
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0001012
- Lead Sponsor
- Yuhan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 36
1. healthy male 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, immune system, musculoskeletal, otorhinolaryngeal, mental disorder, especially in gastrointestinal tract.
2.Subject who has history of surgical operation or diseases related to gastrointestinal symtom (e.g. crohn's disease, ulcer etc except appendectomy or simple for herina)
3. Subject who is hypersensitive to YH4808, diclofenac or drug containing components of rabamipide, revaprazan, NSAIDs(Nonsteroidal anti-inflammatory drugs), etc.
4. Other exclusions apply.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUClast of YH4808, M3, diclofenac;Cmax of YH4808, M3, diclofenac
- Secondary Outcome Measures
Name Time Method AUCinf, T1/2, Tmax of YH4808. M3, diclofenac, M8