Phase 1 Study of SK3530 to Investigate of the Effect of Food
Phase 1
Completed
- Conditions
- Erectile Dysfunction
- Registration Number
- NCT00443625
- Lead Sponsor
- SK Chemicals Co., Ltd.
- Brief Summary
This study was designed to investigate the food effect of SK3530 on the pharmacokinetics (PKs).
- Detailed Description
The PDE5 inhibitor, SK3530, is expected to be taken concomitantly with food. The food interaction studies of other PDE5 inhibitors (Viagra, Levitra and cialis) have already accomplished and the results have provided useful information to the patients. The objective of this study is to compare the pharmacokinetics (PKs) of SK3530 and its metabolite (SK3541) under the fasted and fed (low-fat meal and high-fat meal) conditions.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
Inclusion Criteria
- ages 19 to 50
- body weight of (IBM) ± 20%
Exclusion Criteria
- cardiovascular disease
- color-blindness or weakness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method PK parameters - AUC, Cmax, Tmax
- Secondary Outcome Measures
Name Time Method PK parameters-t1/2