Study to compare pharmacokinetics of sildenafil chewable tablet with those of sildenafil film-coated tablet
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0000419
- Lead Sponsor
- Korea United Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 60
1. Healthy male volunteers between the ages of 20 and 55 years at screening
2. Subjects with a body weight within ± 20% of their ideal weight and over 55kg
3. Subjects have to be able to read, hear, and understand the detail of the study, and should decide to participate in the study volntarily and follow the study directions and provide written informed consent.
1. History of hypersentivity to sildenafil citrate
2. Administration of organic nitrates
3. Subject who has retinitis pigmentosa
4. Current use of other PDE5 inhibitors such as VIAGRA, CIALIS, LEVITRA,ZYDENA, MVIX, and so on
5. Visual field loss due to non-arterial anterial ischemic optic neuropathy
6. Subjects with systolic blood pressure = 100 mmHg or = 150 mmHg, or diastolic blood pressure = 50 mmHg or = 145 mmHg, or with pulse rate < 45 bpm or > 100 bpm
7. Subjects with AST or ALT count, the upper limit of reference range in excess of 1.25 times, or total bilirubin, the upper limit of reference range in excess of 1. 5 times
8. Presence or history of cardiovascular, pulmonary, renal, endocrine, hematologic, gastrointestinal, central nervous system, psychiatric, or malignant diseases
9. heavy drinker (more than 21 units/week) or heavy smoker (more than 20 cigarettes/day)
10. Use of any prescription drug, herbal medications within 14 days, or any over-the-counter medication within 7 days prior to scheduled study drug administration
11. Use of any other investigational drugs within 3 months prior to scheduled study drug administration
12. Donation of whole blood within 2 months or any blood products within 1 month, prior to scheduled study drug administration
13. Use of drugs which are P450 inducers or inhibitors (e.g. Phenobarbital) within 1 month prior to scheduled study drug administration
14. Current or previous abuse of drugs or alcohol
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax of sildenafil;AUC of sildenafil
- Secondary Outcome Measures
Name Time Method tmax of sildenafil;Half-life of sildenafil;Cmax of UK-103320;AUC of UK-103320;tmax of UK-103320;Half-life of UK-103320