A randomized, Open-Label, Single dose, Crossover Study to Evaluate the Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers
Not Applicable
Completed
- Conditions
- Not Applicable
- Registration Number
- KCT0000319
- Lead Sponsor
- Hanmi Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 54
Inclusion Criteria
1)Age between 20 and 45
2)Weight: over 55kg and 18.53)Have to give their consent to participating clinical trial by oneself
Exclusion Criteria
Has a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc>430ms or uncontrolled arrhythmia
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC of Sildenafil;Cmax of Sildenafil
- Secondary Outcome Measures
Name Time Method AUC of N-desmethylsildenafil;Cmax of N-desmethylsildenafil